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1.  Consistent Condom Use Increases the Colonization of Lactobacillus crispatus in the Vagina 
PLoS ONE  2013;8(7):e70716.
Non-hormonal contraception methods have been widely used, but their effects on colonization by vaginal lactobacilli remain unclear.
To determine the association between non-hormonal contraception methods and vaginal lactobacilli on women’s reproductive health.
The cross-sectional study included 164 healthy women between 18–45 years of age. The subjects were divided into different groups on the basis of the different non-hormonal contraception methods used by them. At the postmenstrual visit (day 21 or 22 of the menstrual cycle), vaginal swabs were collected for determination of Nugent score, quantitative culture and real-time polymerase chain reaction (PCR) of vaginal lactobacilli. The prevalence, colony counts and 16S rRNA gene expression of the Lactobacillus strains were compared between the different groups by Chi-square and ANOVA statistical analysis methods.
A Nugent score of 0–3 was more common in the condom group (93.1%) than in the group that used an interuterine device(IUD) (75.4%), (p = 0.005). The prevalence of H2O2-producing Lactobacillus was significantly higher in the condom group (82.3%) than in the IUD group (68.2%), (p = 0.016). There was a significant difference in colony count (mean ± standard error (SE), log10colony forming unit (CFU)/ml) of H2O2-producing Lactobacillus between condom users (7.81±0.14) and IUD users (6.54±0.14), (p = 0.000). The 16S rRNA gene expression (mean ± SE, log10copies/ml) of Lactobacillus crispatus was significantly higher in the condom group (8.09±0.16) than in the IUD group (6.03±0.18), (p = 0.000).
Consistent condom use increases the colonization of Lactobacillus crispatus in the vagina and may protect against both bacterial vaginosis (BV) and human immunodeficiency virus (HIV).
PMCID: PMC3720897  PMID: 23894682
2.  Effects of Oral, Vaginal, and Transdermal Hormonal Contraception on Serum Levels of Coenzyme Q10, Vitamin E, and Total Antioxidant Activity 
The use of the transdermal contraceptive patch is associated with greater bioavailability of ethinyl estradiol (EE) compared with contraceptive vaginal ring or oral contraceptives (OC). We compared the influences of three contraceptive methods (OC, vaginal ring, and transdermal patch) on serum levels of coenzyme Q10, α-tocopherol, γ-tocopherol and total antioxidant capacity in premenopausal women. Blood samples from 30 premenopausal women who used hormonal contraception for at least 4 months were collected. Forty subjects who did not use any contraception were studied as control. Serum levels of coenzyme Q10, α-tocopherol and γ-tocopherol were measured by high-pressure liquid chromatography. Serum samples were also assayed for total antioxidant capacity (TAOC). Serum levels of coenzyme Q10 and α-tocopherol were found to be significantly lower (P < .05) in all three contraceptive users compared with controls. Contraceptive patch users had the lowest levels of coenzyme Q10 levels compared with normal subjects. Serum TAOC levels were significantly lower (P < .05) among the contraceptive user groups. Alterations in coenzyme Q10 and α-tocopherol induced by hormonal contraception and the potential effect(s) of exogenous ovarian hormones should be taken into consideration in future antioxidant research.
PMCID: PMC2929620  PMID: 20814444
3.  Association Between Tampon Use and Choosing the Contraceptive Vaginal Ring 
Obstetrics and gynecology  2010;115(4):735-739.
To estimate whether tampon users are more likely to select the contraceptive vaginal ring than combined oral contraceptive pills (OCPs).
The Contraceptive Choice Project is a longitudinal study of 10,000 St. Louis-area women promoting the use of long-acting, reversible methods of contraception and evaluating user continuation and satisfaction for all reversible methods. We performed univariable and multivariable analyses of the 311 women who were asked about tampon use at the time of enrollment and who chose the contraceptive vaginal ring or OCPs to assess the association of tampon use and choice of combined hormonal method.
Among contraceptive vaginal ring and OCP users, 247 (79%) reported using tampons. Contraceptive vaginal ring users were not significantly different than OCP users in terms of age, race or ethnicity, marital status, insurance, BMI, and parity. Adjusted analysis indicates tampon users were more likely to choose the contraceptive vaginal ring instead of OCPs (adjusted RR=1.34; 95%CI: 1.01–1.78). Women with previous contraceptive vaginal ring experience were also more likely to choose the contraceptive vaginal ring (adjusted RR=1.96; 95%CI: 1.6–2.4). Recent OCP use did not influence method choice.
In our baseline analysis of the Contraceptive Choice Project, tampon users were more likely to choose the contraceptive vaginal ring than OCPs. Use of tampons could be considered an indicator for the initial acceptability of the contraceptive vaginal ring, but all women should be offered the contraceptive vaginal ring regardless of experience with tampon use.
PMCID: PMC3119479  PMID: 20308832
4.  Effects of Long-Term Use of Nonoxynol-9 on Vaginal Flora 
Obstetrics and gynecology  2006;107(1):136-143.
Products containing nonoxynol-9 have been used as spermicidal contraceptives for many years, but limited data have been published describing the long-term effects of nonoxynol-9 use on the vaginal microbial ecosystem. This longitudinal study was conducted to examine the effects of nonoxynol-9 on the vaginal ecology.
Vaginal swabs were obtained from 235 women enrolled in a randomized clinical trial before initiation of use of 1 of 5 different formulations of nonoxynol-9 for contraception, and up to 3 more samples were gathered over 7 months of use. The swab samples were evaluated in a single laboratory. The prevalence of several constituents of the normal vaginal flora was evaluated. The associations between nonoxynol-9 dosage, formulation, average product use per week, and number of sex acts per week were calculated.
The changes in prevalence of vaginal microbes after nonoxynol-9 use were minimal for each of the different nonoxynol-9 formulations. However, when both nonoxynol-9 concentration and number of product uses are taken into account, nonoxynol-9 did have dose-dependant effects on the increased prevalence of anaerobic gram-negative rods (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.1–5.3), H2O2-negative lactobacilli (OR 2.0, 95% CI 1.0–4.1), and bacterial vaginosis (OR 2.3, 95% CI 1.1–4.7).
This study demonstrated that most nonoxynol-9 users experienced minimal disruptions in their vaginal ecology. There were no differences between the different formulations evaluated with respect to changes in vaginal microflora. However, independent of the nonoxynol-9 formulation, there was a dose-dependent effect with increased exposure to nonoxynol-9 on the risk of bacterial vaginosis and its associated flora.
PMCID: PMC1380307  PMID: 16394051
5.  New and emerging contraceptives: a state-of-the-art review 
The first hormonal contraceptive was introduced onto the market in several countries 50 years ago; however, the portfolio of contraceptive methods remains restricted with regards to their steroid composition, their cost, and their ability to satisfy the requirements of millions of women/couples in accordance with their different reproductive intentions, behaviors, cultures, and settings.
A literature review was conducted using Medline, Embase, and Current Contents databases, up to September 1, 2013 to identify publications reporting new contraceptives in development using combinations of the search terms: contraception, contraceptives, oral contraceptives, patch, vaginal ring, implants, intrauterine contraceptives, and emergency contraception (EC). Also, several experts in the field were also consulted to document ongoing projects on contraception development. Additionally, the website was searched for ongoing studies on existing contraceptive methods and new and emerging female contraceptives developed over the past 5 years. Information was also obtained from the pharmaceutical industry.
Early sexual debut and late menopause means that women may require contraception for up to 30 years. Although oral, injectable, vaginal, transdermal, subdermal, and intrauterine contraceptives are already available, new contraceptives have been developed in an attempt to reduce side effects and avoid early discontinuation, and to fulfill women’s different requirements. Research efforts are focused on replacing ethinyl-estradiol with natural estradiol to reduce thrombotic events. In addition, new, less androgenic progestins are being introduced and selective progesterone receptor modulators and new delivery systems are being used. In addition, research is being conducted into methods that offer dual protection (contraception and protection against human immunodeficiency virus transmission), and contraceptives for use “on demand.” Studies are also investigating non-hormonal contraceptive methods that have additional, non-contraceptive benefits.
The most pressing need worldwide is, first, that the highly effective contraceptive methods already available should be affordable to most of the population and also that these methods should fulfill the needs of women of different ages and with different reproductive requirements. The development of new contraceptive methods should also take advantage of the knowledge obtained over the past 30 years on gamete physiology and gamete interaction to avoid the use of steroid compounds.
PMCID: PMC3933723  PMID: 24570597
emerging contraceptives; patch; vaginal ring; intrauterine devices; spray; emergency contraceptives
Contraception  2012;87(3):319-330.
Steady progress in contraception research has been achieved over the past 50 years. Hormonal and non-hormonal modern contraceptives have improved women’s lives by reducing different health conditions that contributed to considerable morbidity. However the contraceptives available today are not suitable to all users and the need to expand contraceptive choices still exists. Novel products such as new implants, contraceptive vaginal rings, transdermal patches and newer combinations of oral contraceptives have recently been introduced in family planning programs and hormonal contraception is widely used for spacing and limiting births. Concerns over the adverse effects of hormonal contraceptives have led to research and development of new combinations with improved metabolic profile. Recent developments include use of natural compounds such as estradiol (E2) and estradiol valerate (E2V) with the hope to decrease thrombotic risk, in combination with newer progestins derived from the progesterone structure or from spirolactone, in order to avoid the androgenic effects. Progesterone antagonists and progesterone receptor modulators are highly effective in blocking ovulation and preventing follicular rupture and are undergoing investigations in the form of oral pills and in semi long-acting delivery systems. Future developments also include the combination of a contraceptive with an antiretroviral agent for dual contraception and protection against sexually transmitted diseases, to be used before intercourse or on demand, as well as for continuous use in dual-protection rings. Alhough clinical trials of male contraception have reflected promising results, limited involvement of industry in that area of research has decreased the likelihood of having a male method available in the current decade. Development of non-hormonal methods are still at an early stage of research, with the identification of specific targets within the reproductive system in ovaries and testes, as well as interactions between spermatozoa and ova. It is hoped that the introduction of new methods with additional health benefits would help women and couples with unmet needs to obtain access to a wider range of contraceptives with improved acceptability.
PMCID: PMC3530627  PMID: 22995540
Contraception; progestins; nestorone; estetrol; progesterone receptor modulators; long-acting delivery systems; vaginal rings; transdermal contraception
7.  Influence of combined oral contraceptives on the periodontal condition 
Journal of Applied Oral Science  2012;20(2):253-259.
Most studies investigating the impact of oral contraceptives have been performed some years ago, when the level of sexual hormones was greater than the actual formulations.
The aim of this study was to evaluate the effects of current combined oral contraceptives (COC) on periodontal tissues, correlating the clinical parameters examined with the total duration of continuous oral contraceptive intake.
Material and methods
Twenty-five women (19-35 years old) taking combined oral contraceptives for at least 1 year were included in the test group. The control group was composed by 25 patients at the same age range reporting no use of hormone-based contraceptive methods. Clinical parameters investigated included pocket probing depth (PD), clinical attachment level (CAL), sulcular bleeding index (SBI) and plaque index (Pl.I). Data were statistically evaluated by unpaired t test, Pearson's correlation test and Spearman's correlation test.
The test group showed increased PD (2.228±0.011 x 2.154±0.012; p<0.0001) and SBI (0.229±0.006 x 0.148±0.005, p<0.0001) than controls. No significant differences between groups were found in CAL (0.435±0.01 x 0.412±0.01; p=0.11). The control group showed greater Pl.I than the test group (0.206±0.007 x 0.303±0.008; p<0.0001). No correlation between the duration of oral contraceptive intake, age and periodontal parameters was observed.
These findings suggest that the use of currently available combined oral contraceptives can influence the periodontal conditions of the patients, independently of the level of plaque accumulation or total duration of medication intake, resulting in increased gingival inflammation.
PMCID: PMC3894772  PMID: 22666846
Oral contraceptives; Estrogens; Progesterone; Gingivitis; Periodontitis
8.  Combined Oral Contraceptive Pills: Profile of Acceptors in a Tertiary Hospital in South-South Nigeria 
Combined oral contraceptive pills were the first contraceptive method to provide sexual freedom of choice for women through reliable, personal and private control of fertility. They are the most widely used hormonal contraceptives and also the most popular non-surgical method of contraception.
To review the profile of acceptors of combined oral contraceptive pills at the University of Uyo Teaching Hospital, Uyo.
An 8 year review of all clients that accepted combined oral contraceptive pills in the family planning clinic.
There were 1,146 new contraceptive acceptors during the period of study out of which 309 (27.9%) accepted the pills. Majority of the clients were between 20 and 29 years of age (54.0%), were multiparous (72.8%), Christians (99.7%) and 61.2% had tertiary level education. Two hundred and fifty-five women (82.5%) desired to use combined oral contraceptive pills to space births while 7.8% wanted to limit child bearing. There was a high discontinuation rate among the women (45.0%) and out of these 87.9% of the clients changed to other contraceptive methods. All the clients commenced their pills within seven days of menstruation and only the low dose monophasic preparations were available in the family planning unit and thus were given to the clients.
Women who accept to initiate combined oral contraceptive pills in our center are young, well educated, multiparous women who want to space their pregnancies. However, due to the high discontinuation rate among the clients, there is need for further studies evaluating reasons for the high discontinuation rate, exploring interactions between clients and providers’ and also providers’ attitude towards combined pills in our environment.
PMCID: PMC3180757  PMID: 21969170
Oral contraceptive pills; Acceptance; Nigeria
9.  Cervical dysplasia and cancer and the use of hormonal contraceptives in Jamaican women 
BMC Women's Health  2008;8:9.
This study was conducted to determine whether use of hormonal contraceptives is associated with cervical dysplasia and cancer in a population where there is widespread use of hormonal contraception and the rates of cervical cancer remain high at 27.5/100,000.
A case-control study was conducted among women visiting the colposcopy and gynaelogical clinics at a tertiary referral hospital. Two hundred and thirty six cases CIN I (72), II (59), III (54), cancer (51) and 102 controls, consented and were interviewed on use of contraceptives using a structured questionnaire. Logistic regression was used to determine odds ratios (ORs) and 95% confidence intervals (CIs) associated with use of hormonal contraception in cases and controls and in low and high risk cases. Recruitment was carried out from 2001–2002.
Contraceptives used were: oral contraceptives – 35%, injections (depot medroxy progesterone acetate (Depo-provera) – 10%, Intrauterine devices – 2%, combinations of these and tubal ligation – 30%. 23% reported use of 'other' methods, barrier contraceptives or no form of contraception. Barrier contraceptive use was not significantly different between cases and controls. Current and/or past exposure to hormonal contraceptives (HC) by use of the pill or injection, alone or in combination with other methods was significantly higher in the cases. In multivariate analysis with age and number of sexual partners as co-variates, use of hormonal contraception was associated both with disease, [OR, 1.92 (CI 1.11, 3.34; p = 0.02] and severity of the disease [OR, 2.22 (CI 1.05, 4.66) p = 0.036]. When parity and alcohol consumption were added to the model, hormonal contraception was no longer significant. The significant association with high risk disease was retained when the model was controlled for age and number of sexual partners. Depo-provera use (with age and number of sexual partners as covariates) was also associated with disease [OR, 2.43 (CI 1.39, 4.57), p = 0.006] and severity of disease [OR 2.51 (1.11, 5.64) p = 0.027]. With parity and alcohol added to this model, depo-provera use retained significance. Exposure to HC > 4 years conferred more risk for disease and severity of disease.
Hormonal contraception did confer some risk of dysplasia and women using HC should therefore be encouraged to do regular Pap smear screening.
PMCID: PMC2430195  PMID: 18513406
10.  Effects of Depot Medroxyprogesterone Acetate and 20 μg Oral Contraceptives on Bone Mineral Density 
Obstetrics and gynecology  2008;112(4):788-799.
Hormonal contraceptives may adversely affect bone mineral density . However, racial differences and the reversibility of these changes are poorly understood. This study measured bone mineral density changes during hormonal contraceptive use and after discontinuation in a triethnic population.
Bone mineral density was measured every 6 months for up to 3 years in 703 white, black, and Hispanic women using oral contraceptives (OCPs), depot medroxyprogesterone acetate (DMPA), or nonhormonal contraception, and in 68 DMPA discontinuers for up to 2 additional years. Mixed-model regression analyses were used to estimate the percentage change in bone mineral density for each contraceptive method.
Over 3 years, DMPA and OCP users lost more bone mineral density than nonhormonal contraception users (−3.7% and −0.5% vs. +1.9% at lumbar spine, and −5.2% and −1.3% vs. +0.6% at femoral neck, respectively). No differences were observed by race in bone mineral density changes that resulted from DMPA or OCP use. However, DMPA users aged 16–24 years lost more bone mineral density at the spine (4.2% vs. 3.2%, P=.006) and femoral neck (6.0% vs. 4.2%, P=.001) than those aged 25–33 years. After DMPA discontinuation, women who selected nonhormonal contraception gained bone mineral density (+4.9% at spine; +3.2% at femoral neck) while those who selected OCP recovered spinal (+2.3%), but not femoral neck bone mineral density (−0.7%).
Use of very low-dose OCP may result in a small amount of bone loss. DMPA use results in greater bone loss, but this is largely reversible at the spine. Use of very low-dose OCPs after DMPA discontinuation may slow bone recovery.
PMCID: PMC2745348  PMID: 18827121
11.  Assessment of fertility control efforts in a selected area of Karachi, Pakistan 
The Ulster Medical Journal  2007;76(3):144-145.
To investigate the impact of fertility control efforts on reducing fertility and to study the contributory role of fertility inhibiting factors viz, age of the marriage, breast feeding and post-partum amenorrhea, abortion and use of contraceptives in selected area in Karachi, Pakistan. The aim was to estimate the gap between knowledge of contraceptives and its practice i.e. KAP-GAP as well as to determine the level of unmet need in the PIB colony in Karachi.
Data Source
A sample survey was conducted in PIB colony in Karachi from October 2005 to November 2005 by interviewing 340 married women in reproductive ages. The data was tabulated and John Bongaarts technique1 was used to analyse the success of fertility control efforts in the selected area.
Of the total of 340 respondents, 38% were currently using contraceptive methods with 26% using OCP's and 12% were condom users. A slight reduction in total fertility (TFR) was noticed.
The population policy of Pakistan envisages achieving population stabilization in 2020 by reducing the annual rate of population growth from 1.9% to 1.3% and TFR at 2.1. This target requires strenuous efforts to make the concept of small family an accepted milieu through an eagerly designed communication and education campaign. Concentration on proximate determinants of fertility particularly breast feeding and prolonging birth interval will not generate opposition from the community because these concepts are in accordance with Islamic injunctions and teachings.
PMCID: PMC2075572  PMID: 17853640
12.  FSWs Typology and Condoms Use Among HIV High Risk Groups in Sindh, Pakistan: A Developing Country Perspective 
We aimed to determine the association of FSWs typology with condom use among HIV high risk groups in Sindh, Pakistan
HIV is growing rapidly worldwide resulting in estimated 34 million population [1]. Recently, its epidemic has spread in Africa, Latin America, and the Caribbean, and most parts of Asia [2]. According to Antenatal sero surveillance study conducted in 2011 by Agriteam canada, it’s prevalence in Pakistan is <0.1 [3].Focusing narrowly, its prevalence in Sindh, (one of the provinces of Pakistan) is similar in general population, but it is in the phase of concentrated epidemic (having more than 5% of prevalence in high risk groups)in vulnerable groups like IDUs and Male sex workers and transgender [4].
Sexual intercourse has been identified as major route especially in HIV high risk groups including male sex workers, female sex workers (FSWs), transgender (hijras) and IV drug users. Among them, FSWs are at high risk because of unprotected sex and illicit drug use. Their prevalence is found to be 30.7% in low and middle income countries [5]. South Asia contributed with 12.63 lakh FSW in India only [6]. On the basis of their station of work, they are categorized into facility based (kothikhana, brothel or home) and mobile (street, mobile or beggars). They use different preventive measures including condom for their protection from HIV [7]. It varies with availability and access [8] . FSWs typology have different cliental and mode of action, therefore, it important to explore the preventive methods.
Data was extracted from Second Generation Surveillance, Integrated behavioral and biological survey, Round IV for HIV infection conducted by Agriteam Canada in partnership with National AIDS Control Program, Pakistan in 2011. It was a cross sectional survey for high risk groups including FSWs from Pakistan. It was ethically approved by Review Board of the Public Health Agency of Canada and HOPE International’s Ethical Review Board, Pakistan. From Sindh province, FSWs based in Karachi, Sukkur and Larkana were recruited. Considering typology, they were categorized as mobile or facility based. After informed consent, socio-demographic and risk behavior were inquired. HIV was tested by ELISA/EIA and confirmed by Western Blot. Data was analyzed on SPSS 19. Continuous variables were expressed as mean±SD while categorical as frequency(%). Logistic regression assessed the association of FSWs typology with condoms use among HIV high risk groups.
Out of 4567 high risk population, 1127 were identified as FSWs. Mean age was 26.9 years. Most of them were facility based (72.8%) and 81.3% used condoms. Typology, age, education, duration of involvement, number of client per day, number of paid oral sex per month, knowledge about STI and knowledge about drop in center were significantly associated with condom use among HIV high risk groups.
Majority of facility based FSWs use condoms to prevent HIV infection. Awareness and access to home based FSWs should be increased. It may help in targeting and designing preventive strategies for them at government and mass level.
PMCID: PMC3692789
FSW; typology; condoms; HIV high risk groups; Pakistan
13.  Emergency hormonal contraception usage in genitourinary medicine clinic attenders. 
Genitourinary Medicine  1996;72(3):217-219.
OBJECTIVE: To assess the indications for usage of emergency hormonal contraception amongst a population of London genitourinary medicine clinic attenders. METHODS: In a prospective study, 150 consecutive women receiving emergency hormonal contraception (EHC) were enrolled. The attending doctor completed a questionnaire of patient details and prescribed EHC with prophylactic prochlorperazine. Follow-up was arranged three weeks later, at which time outcomes and side-effects of therapy were recorded. For those women who did not reattended as planned case notes were reviewed at three months. RESULTS: Of 150 women surveyed, 100 (66%) reported contraceptive method failure, 48 (32%) had used no contraception at the time of last sexual intercourse and two requested EHC after sexual assault. Ninety three (62%) reported condom failure, 7 (5%) oral contraceptive pill failure. Seventy five (50%) had used EHC before (range 1-10 times). Seventy one (47%) women reattended within three months. Five (3.3%) of the 150 women were pregnant; none of these cases had experienced nausea or vomiting whilst taking EHC. Side-effects were reported by 22 (31%) of the 71 patients who reattended. Nine (6%) women had been followed-up in the family planning advisory clinic. Of the 71 women who reattended, 39 (55%) reported that their preferred future method of contraception would be condoms. Of the 150 women 19 (13%) underwent tests for sexually transmissible infections within one month of presentation. CONCLUSIONS: EHC usage in this population was associated with a failure rate of at least 3.3% and an overall side effect rate of 31%. Despite requests for emergency contraception because of condom failure many elected to continue using condoms as their preferred method of contraception. The majority of women (53%) did not return for follow-up or family planning advice, and so we believe that future contraceptive plans must be addressed at the time EHC is prescribed.
PMCID: PMC1195655  PMID: 8707328
14.  Vaginal ring delivery of selective progesterone receptor modulators for contraception 
Contraception  2012;87(3):314-318.
Vaginal ring delivery of selective progesterone receptor modulators (SPRMs) are under development to address limitations of current hormonal methods that affect use and effectiveness. This method would be appropriate for use in women with contraindications to, or preferences to avoid, estrogens. A contraceptive vaginal ring (CVR) also eliminates the need for daily dosing, and therefore might improve the effectiveness of contraception. The principle contraceptive effect of SPRMs is the suppression of ovulation. One limiting factor of chronic SPRM administration is the development of benign endometrial thickening characterized as PRM-associated endometrial changes. Ulipristal acetate is approved for use as an emergency contraceptive pill, but no SPRM is approved for regular contraception. The Population Council is developing an ulipristal acetate CVR for regular contraception. The CVR studied is of a matrix design composed of micronized UPA mixed in a silicone rubber matrix The target product is a ring designed for continuous use over 3 months delivering near steady-state drug levels that will suppress ovulation. Results from Phase 1–2 studies demonstrate that suppression of ovulation occurs with UPA levels above 6–7 ng/mL.
PMCID: PMC3657703  PMID: 23040126
15.  Prospective study of weight change in new adolescent users of DMPA, NET-EN, COCs, non-users and discontinuers of hormonal contraception 
Contraception  2010;81(1):30-34.
Weight gain is commonly reported as a side effect of hormonal contraception and can lead to method discontinuation or reluctance to initiate the method. The purpose of this study was to investigate weight change in adolescent aged 15-19 years who were new users of depot-medroxyprogesterone acetate (DMPA), norethisterone enanthate (NET-EN), combined oral contraceptives (COCs), and non-users of hormonal contraception.
Study design
This longitudinal study recruited initiators of DMPA (n=115), NET-EN (n=115), COCs (n=116), and non-users of contraception (n=144). Participants were followed-up for 4-5 years and height, weight and contraceptive use was recorded at each visit.
Women using DMPA or NET-EN throughout or switching between the two, had gained an average of 6.2 kg compared to average increases of 2.3 kg in the COC group, 2.8 kg in non-users and 2.8 kg among discontinued users of any method (p=0.02). There was no evidence of a difference in weight gain between women classified as non-obese or classified as overweight/obese in any of the four study groups at baseline.
There is fairly strong evidence that hormonal injectable users gain more weight than COC users, discontinuers and non-users of contraception.
PMCID: PMC3764463  PMID: 20004270
DMPA; NET-EN; COCs; weight; adolescents
16.  Hormonal contraceptive use and risk of HIV-1 transmission: a prospective cohort analysis 
The Lancet Infectious Diseases  2011;12(1):19-26.
Hormonal contraceptives are used widely but their effects on HIV-1 risk are unclear.
We followed 3790 heterosexual HIV-1 serodiscordant couples from seven African countries participating in two longitudinal HIV-1 incidence studies. Among hormonal contraceptive users (including injectable and oral contraceptive users) and nonusers, we compared rates of HIV-1 acquisition in women and HIV-1 transmission from women to men.
Among 1314 couples in which the HIV-1 seronegative partner was female, HIV-1 acquisition rates were 6.61 and 3.78 per 100 person-years among hormonal contraceptive users and nonusers (adjusted hazard ratio [AHR]=1.98, 95% confidence interval [CI] 1.06–3.68, p=0.03). Among 2476 couples in which the HIV-1 seronegative partner was male, HIV-1 transmission rates from women to men were 2.61 and 1.51 per 100 person-years in those whose partners currently used versus did not use hormonal contraception (AHR=1.97, 95% CI 1.12–3.45, p=0.02). In subgroup analysis, injectable contraceptive users had increased risk for acquiring and transmitting HIV-1 to their partner and HIV-1 seropositive women using injectable contraception had higher genital HIV-1 RNA concentrations, suggesting a mechanism for increased transmission risk. Oral contraceptives were used too infrequently to draw definitive conclusions about HIV-1 risk.
Women should be counseled about potentially increased risk of HIV-1 acquisition and transmission with hormonal contraception, particularly injectable methods, and about the importance of dual protection with condoms to decrease HIV-1 risk. Non-hormonal or lower-dose hormonal contraceptive methods should be considered for women with or at-risk for HIV-1.
National Institutes of Health (R03 HD068143, R01 AI083034, P30 AI027757, and T32 AI007140) and the Bill and Melinda Gates Foundation (26469 and 41185).
PMCID: PMC3266951  PMID: 21975269
HIV-1; serodiscordant couples; Africa; hormonal contraception
17.  Vaginal microbiome in women from Greenland assessed by microscopy and quantitative PCR 
BMC Infectious Diseases  2013;13:480.
Bacterial vaginosis (BV) is a common condition, although its aetiology remains unexplained. The aim of this study was to analyse the composition of vaginal microbiota in women from Greenland to provide a quantitative description and improve the understanding of BV.
Self-collected vaginal smears and swabs were obtained from 177 women. The vaginal smears were graded for BV according to Nugent’s criteria. The vaginal swab samples were analysed by 19 quantitative PCRs (qPCRs) for selected vaginal bacteria and by PCR for four sexually transmitted infections (STIs).
STIs were common: Mycoplasma genitalium 12%, Chlamydia trachomatis 7%, Neisseria gonorrhoeae 1%, and Trichomonas vaginalis 0.5%. BV was found in 45% of women, but was not associated with individual STIs. Seven of the 19 vaginal bacteria (Atopobium vaginae, Prevotella spp., Gardnerella vaginalis, BVAB2, Eggerthella-like bacterium, Leptotrichia amnionii, and Megasphaera type 1) had areas under the receiver operating characteristic (ROC) curve > 85%, suggesting they are good predictors of BV according to Nugent. Prevotella spp. had the highest odds ratio for BV (OR 437; 95% CI 82–2779) in univariate analysis considering only specimens with a bacterial load above the threshold determined by ROC curve analysis as positive, as well as the highest adjusted odds ratio in multivariate logistic regression analysis (OR 4.4; 95% CI 1.4-13.5). BV could be subdivided into clusters dominated by a single or a few species together.
BV by Nugent score was highly prevalent. Two of seven key species (Prevotella spp. and A. vaginae) remained significantly associated with BV in a multivariate model after adjusting for other bacterial species. G. vaginalis and Prevotella spp. defined the majority of BV clusters.
PMCID: PMC3853076  PMID: 24131550
Bacterial vaginosis; Nugent criteria; Sensitivity; Specificity; ROC curve analysis; Clusters
18.  Continuation rates of oral hormonal contraceptives in a cohort of first-time users: a population-based registry study, Sweden 2005–2010 
BMJ Open  2013;3(10):e003401.
To investigate if continuation rates in first-time users of oral hormonal contraceptives differed between different formulations and to measure if the rates were related to the prescribing categories, that is, physicians and midwives.
A longitudinal national population-based registry study.
The Swedish prescribed drug register.
All women born between 1977 and 1994 defined as first-time users of hormonal contraceptives from 2007 to 2009 (n=226 211).
Main outcome measures
A tendency to switch the type of hormonal contraceptive within 6 months use and repeated dispensation identical to the first were estimated as percentages and relative risks (RRs). Physicians’ and midwives’ prescription patterns concerning the women's continuation rates of oral hormonal contraceptive type.
In Sweden, there were 782 375 women born between 1977 and 1994 at the time of the study. Of these, 226 211 women were identified as first-time users of hormonal contraceptives. Ethinylestradiol+levonorgestrel, desogestrel-only and ethinylestradiol+drospirenone were the hormonal contraceptives most commonly dispensed to first-time users at rates of 43.3%, 24.4% and 11.1%, respectively. The overall rate of switching contraceptive types in the first 6 months was 11.3%, which was highest for desogestrel-only (14.3%) and lowest for ethinylestradiol+drospirenone (6.6%). The switching rate for all three products was highest in the 16-year to 19-year age group. Having a repeated dispensation identical to the initial dispensation was highest for users of ethinylestradiol either combined with levonorgestrel or drospirenone, 81.4% and 81.2%, respectively, whereas this rate for the initial desogestrel-only users was 71.5%. The RR of switching of contraceptive type within the first 6 months was 1.35 (95% CI 1.32 to 1.39) for desogestrel-only and 0.63 (0.59 to 0.66) for ethinylestradiol+drospirenone compared with ethinylestradiol+levonorgestrel as the reference category. There were no differences in the women's continuation rates depending on the prescriber categories.
Desogestrel-only users conferred the highest switcher rate to another hormonal contraceptive within a 6-month period. Users of ethinylestradiol+levonorgestrel were more prone to switch to another product within 6 months than women using ethinylestradiol+drospirenone. These findings may be of clinical importance when tailoring hormonal contraceptives on an individual basis.
PMCID: PMC3808784  PMID: 24141970
Public Health
19.  Effects of switching from oral to transdermal or transvaginal contraception on markers of thrombosis 
Contraception  2008;78(6):451-458.
The study was conducted to determine the impact of switching from oral to transdermal patch or vaginal ring contraception on biomarkers of thrombosis.
Study Design
Current healthy oral contraceptive (OC) users were randomized to switch to either a contraceptive ring (CR) or patch (CP) and underwent phlebotomy to measure surrogate biomarkers of thrombosis (sex hormone binding globulin (SHBG), free protein S, and activated protein C-resistance (APC-r)) before switching, and during the 4th cycle of use of the new method.
Of 142 reproductive age women enrolled, 120 sample pairs were available for analysis. SHBG increased significantly from baseline in CP users (mean change (95% CI) +29.9 nM (9.6, 50) but not in CR users −1.6 (−16.6, 13.5). Protein S decreased significantly from baseline in CP users (mean change −7.1% (−12.1, −2.1), but increased significantly in CR users +5.3% (1.1, 9.6). The APC-r ratio did not undergo a significant change from baseline in either group [CP +0.06 (−0.06, 0.18), CR +0.02 (−0.10, 0.14)] Compared to CR users, subjects using the CP had significantly higher SHBG (187.5 (167.0, 208), 146 (132.6,159.4), p = 0.012), significantly lower protein S (81.8 (76.8, 86.8), 93.6 (89.1, 98.1), p = 0.001), and similar APC-r ratios (2.99 (2.85,3.14), 3.09 (2.96, 3.22), p = 0.3) at the cycle 4 visit.
OC users who switch to the ring exhibit beneficial changes in biomarkers of thrombosis while those switching to the patch display a shift favoring clot formation.
PMCID: PMC2628719  PMID: 19014790
Transdermal; Transvaginal; Hormonal Contraception; Thrombosis; Randomized
20.  `Normal' vaginal microbiology of women of childbearing age in relation to the use of oral contraceptives and vaginal tampons 
Journal of Clinical Pathology  1967;20(4):636-640.
The vaginal microbiology of women attending a family planning clinic was found to be unrelated to the use of oral contraceptives and vaginal tampons.
Beta haemolytic streptococci isolated from this `normal' population were compared with those from 1,104 women attending general practitioners complaining of vaginal discharge. There is a caution regarding the indications for antibiotic therapy.
Observations were made on the effects of contamination of vaginal swabs with yeasts and β-haemolytic streptococci from the vulva. The persistent character of the vaginal flora over a six-month period is described.
PMCID: PMC473527  PMID: 5602581
21.  Lamisil versus clotrimazole in the treatment of vulvovaginal candidiasis 
Background and Objectives
Vaginal candidiasis is a common disease in women during their lifetime and occurs in diabetes patients, during pregnancy and oral contraceptives users. Although several antifungals are routinely used for treatment; however, vaginal candidiasis is a challenge for patients and gynecologists. The aim of the present study was to evaluate terbinafine (Lamisil) on Candida vaginitis versus clotrimazole.
Materials and Methods
In the present study women suspected to have vulvovaginal candidiasis were sampled and disease confirmed using direct smear and culture examination from vaginal discharge. Then, patients were randomly divided into two groups, the first group (32 cases) was treated with clotrimazole and the next (25 cases) with Lamisil. All patients were followed-up to three weeks of treatment and therapeutic effects of both antifungal were compared.
Our results shows that 12 (37.5%) patients were completely treated with clotrimazole during two weeks and, 6(18.8%) patients did not respond to drugs and were refereed for fluconazole therapy. Fourteen (43.8%) patients showed moderate response and clotrimazole therapy was extended for one more week. When Lamisil was administrated, 19 (76.0%) patients were completely treated with Lamisil in two weeks, and 1 (4.0%) of the patients did not respond to the drug and was refereed for fluconazole therapy. Five (20.0%) of our patients showed moderate response and Lamisil therapy was extended for one more week.
Our results show that vaginal cream, 1% Lamisil, could be suggested as a first-line treatment in vulvovaginal candidiasis.
PMCID: PMC3577561  PMID: 23466900
Vulvovaginal candidiasis; Clotrimazole; Terbinafine; Candida albicans
22.  Phase I Randomized Safety Study of Twice Daily Dosing of Acidform Vaginal Gel: Candidate Antimicrobial Contraceptive 
PLoS ONE  2012;7(10):e46901.
Acidform gel, an acid-buffering product that inactivates spermatozoa, may be an effective topical non-hormonal contraceptive. This study was designed to evaluate the safety of vaginal dosing and effects of Acidform on mucosal immune mediators, antimicrobial properties of genital secretions, and vaginal microbiota.
Thirty-six sexually abstinent U.S. women were randomized to apply Acidform or hydroxyethylcellulose (HEC) placebo gel twice daily for 14 consecutive days. Safety was assessed by symptoms and pelvic examination. The impact of gel on mucosal immunity was assessed by quantifying cytokines, chemokines, antimicrobial proteins and antimicrobial activity of genital secretions collected by cervicovaginal lavage (CVL) at screening, 2 hours after gel application, and on days 7, 14 and 21. Vaginal microbiota was characterized at enrollment and day 14 using species-specific quantitative PCR assays.
The median vaginal and cervical pH was significantly lower 2 hours after application of Acidform and was associated with an increase in the bactericidal activity of CVL against E. coli. However, 65% of women who received Acidform had at least one local adverse event compared with 11% who received placebo (p = 0.002). While there was no increase in inflammatory cytokines or chemokines, CVL concentrations of lactoferrin and interleukin-1 receptor antagonist (IL-1ra), an anti-inflammatory protein, were significantly lower following Acidform compared to HEC placebo gel application. There were no significant changes in Lactobacillus crispatus or Lactobacillus jensenii in either group but there was a decrease in Gardnerella vaginalis in the Acidform group (p = 0.08).
Acidform gel may augment mucosal defense as evidenced by an increase in bactericidal activity of genital secretions against E. coli and a decrease in Gardnerella vaginalis colonization. However, Acidform was associated with more irritation than placebo and lower levels of antimicrobial (lactoferrin) and anti-inflammatory (IL-1ra) proteins. These findings indicate the need for additional safety studies of this candidate non-hormonal contraceptive.
Trial Registration NCT00850837
PMCID: PMC3466198  PMID: 23056520
23.  Hormonal contraceptive method choice among young, low-income women: How important is the provider? 
Patient education and counseling  2010;81(3):349-354.
Several new methods are available, but we know little about successful integration of contraceptive technologies into services. We investigated provider factors associated with the initiation of new hormonal methods among women at high-risk of unintended pregnancy.
This cohort study enrolled 1,387 women aged 15–24 starting hormonal contraception (vaginal ring, transdermal patch, oral contraceptive, or injectable) at four family planning clinics in low-income communities. We measured provider factors associated with method choice, using multinomial logistic regression.
Ring and patch initiators were more likely than women starting oral contraceptives to report that they chose their method due to provider counseling (p<0.001). Contraceptive knowledge in general was low, but initiation of a new method, the ring, was associated with higher knowledge about all methods after seeing the provider (p<0.001). Method initiated varied with provider site (p<0.001). These associations remained significant, controlling for demographics and factors describing the provider-patient relationship, including trust in provider and continuity of care.
Women’s reports of provider counseling and of their own contraceptive knowledge after the visit was significantly associated with hormonal method initiated.
Practice Implications
More extensive counseling and patient education should be expected for successful integration of new hormonal methods into clinical practice.
PMCID: PMC2997915  PMID: 20837389
hormonal contraception; adolescents; high-risk women; providers influences; contraceptive choice
24.  Influence of Exogenous Reproductive Hormones on Specific Antibody Production in Genital Secretions after Vaginal Vaccination with Recombinant Cholera Toxin B Subunit in Humans 
Clinical and Vaccine Immunology  2006;13(2):202-207.
The objective of this study was to investigate the influence of exogenous reproductive hormones on the local and systemic production of specific immunoglobulin A (IgA) and IgG antibodies after vaginal vaccination with recombinant cholera toxin subunit B (CTB). Three groups of women using either progesterone-containing intrauterine devices (n = 9), oral contraceptives (n = 8), or no hormonal contraceptive methods (n = 9) were vaginally immunized twice, 2 weeks apart. Cervical secretions, vaginal fluids, and serum were collected before and after vaccination. Total and CTB-specific IgA and IgG antibodies in genital secretions and serum were analyzed by enzyme-linked immunosorbent assay. A majority of the women presented strong CTB-specific IgA and IgG antibody responses in cervicovaginal secretions after vaccination, whereas the antitoxin responses in serum were weaker. Exogenously administered steroid hormones did not seem to have any impact on the production of specific antibodies. Both the frequencies and the magnitudes of IgA and IgG antitoxin responses in genital secretions were comparable among the three immunization groups. An association, in particular for IgA, was found between the magnitudes of the CTB-specific antibody responses in cervical secretions and vaginal fluids after vaccination. The sensitivities and positive predictive values of vaginal antibody analyses to reflect responses in cervical secretions were also high, suggesting that vaginal fluids alone might be used for evaluation of genital immune responses in large-scale vaccination studies in the future.
PMCID: PMC1391940  PMID: 16467326
25.  Marriage decision making, spousal communication, and reproductive health among married youth in Pakistan 
Global Health Action  2011;4:10.3402/gha.v4i0.5079.
Married young women's reproductive needs are a challenge in traditional Pakistani society. The decisions regarding family planning and pregnancy are controlled by the family, often involving complex negotiations. The current study was undertaken to explore how young married women's involvement in the arrangements surrounding their marriage is associated with their ability to negotiate sexual and reproductive health decisions in marriage.
The study explores the associations between young women's involvement in their marriage arrangements and their ability to negotiate for contraceptive use and fertility decisions.
A subset of 1,803 married young women aged 15–24 years was drawn from a nationally representative adolescent and youth survey conducted in Pakistan in 2001–2002 by the Population Council. Regression models were fitted to outcomes: reported agreement with spouse on the number of children to have, current use of contraceptives, intention to use contraceptives in the future, and the time elapsed between marriage and first contraceptive use. Key covariates of interest were variables that measure the involvement of young women in their marriage: (a) having a say in selection of spouse, (b) having met him prior to marriage, and (c) whether he was related to respondent's family. Other factors explored were respondents' mobility outside of household, social role, and decision making in their homes.
Having a say in the selection of a spouse was significantly associated with agreement with spouse over number of children to have, intention to use contraceptives, and the time between marriage and first contraceptive use. These relationships existed after controlling for education, socioeconomic status, mobility outside of house, and decision making in the home.
Women who had decision-making freedom in their parental home carried this ability with them into marriage in their new home and were better able to negotiate about their fertility.
PMCID: PMC3023879  PMID: 21253456
youth; married women; agency; Pakistan

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