Contraception

Clinical Trials

SILCS diaphragm, a new single-size barrier device - COMPLETED

Women who cannot or choose not to use hormonal contraception need additional contraceptive options. Traditional diaphragms require that women be fitted by healthcare clinicians, which is often a barrier to provision in developing countries. The Program for Appropriate Technology in Health (PATH) SILCS diaphragm is a revolutionary diaphragm—it is the first single-size reusable diaphragm that can be used by most women. The SILCS diaphragm was created in an iterative process that incorporated user feedback throughout development. A Phase III contraceptive trial of the SILCS diaphragm, used in combination with either BufferGel® or nonoxynol-9, enrolled 450 couples at 6 U.S. sites. Results show that the SILCS is as effective as the traditional diaphragm. SILCS was granted a CE marking, clearing the way for its sale in Europe. Work is underway to secure U.S. FDA approval.

Meloxicam, a nonsteroidal, anti-inflammatory agent to be used as emergency contraception - COMPLETED

A Phase II trial in Santiago, Chile tested the safety and efficacy of 2 different doses of meloxicam, 15 mg and 30 mg, taken daily for 5 days for the prevention of ovulation. Findings indicate that the 30 mg dose is safe and effective and may offer an alternative to hormonal emergency contraception.

The Woman's Condom, a new female condom - COMPLETED

CONRAD has continued its pioneering work with female condoms that helped lead to the 1993 FDA approval of the first female condom on the U.S. market, the FC Female Condom (formerly Reality® Female Condom), marketed by The Female Health Company. Since 1998, CONRAD has supported PATH in the development of a new female condom known as the Woman's Condom. This new female condom has performed well with good acceptability in initial studies in the U.S. and South Africa. CONRAD collaborated with the California Family Health Council (CFHC) on a study comparing the performance of the Woman's Condom and the FC2 Female Condom. This study compared self-reported clinical failure rates of the 2 condoms, and used vaginal detection of prostate-specific antigen (PSA) as an indicator of condom failure in an effort to demonstrate that this type of trial can replace contraceptive efficacy trials for approval of new female condoms. The study is now in data analysis.

In parallel, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Contraceptive Clinical Trials Network conducted a Phase III contraceptive efficacy study of the Woman's Condom with a nested PSA substudy. This study has been completed; the clinical study report is being drafted for FDA review. 

Cyclofem®, a female injectable hormonal contraceptive - COMPLETED

Cyclofem is a highly effective monthly injectable hormonal contraceptive containing 2 hormones, medroxyprogesterone acetate (MPA) and estradiol cypionate (E2C), that has been studied and used extensively in populations throughout the world, but is not currently approved by the FDA. FDA approval is pivotal to the acceptance of Cyclofem in many countries because of the FDA's rigorous standards for drug safety and efficacy. A pharmacokinetic and pharmacodynamic study in women at CONRAD/EVMS to determine the fate of the 2 hormones in the body after administration of Cyclofem has been completed. Monthly injections of Cyclofem resulted in contraceptive levels of MPA, without accumulation of hormones. This study is the first step in obtaining the FDA approval needed to further expand access to this contraceptive method.

TU/NET-EN male hormonal contraceptive effectiveness trial - COMPLETED

This Phase IIb trial is a collaboration between CONRAD and WHO to determine the safety and efficacy of a long-acting formulation of testosterone (testosterone undecanoate [TU]) combined with a long-acting progestin (norethisterone enanthate [NET-EN]) for sperm suppression and contraceptive efficacy. Ten sites in 7 countries began enrolling trial participants in 2008; enrollment ended in September 2010. Participants received injections every 2 months during the Suppression and Efficacy Phases. While interim data showed that the method suppressed sperm production effectively, further injections were discontinued in April 2011 after a WHO review panel determined that the risks of possible side effects might outweigh the potential benefits to male participants. The side effects experienced by participants were not unexpected, but occurred more often than anticipated. All men still active at that time were transitioned into the Recovery Phase. Results and completion of data analysis are expected by the end of 2013.


 
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