Clinical TrialsMale hormonal contraceptive effectiveness trial
Partner: World Health Organization (WHO)
The collaboration between WHO, CONRAD and the Consortium for Industrial Collaboration in Contraceptive Research (CICCR) made progress in obtaining the regulatory and ethical agreements required to start a Phase II contraceptive effectiveness trial based on a hormonal method for men. This trial will be conducted in seven countries and enroll approximately 400 couples. Recruitment began in mid-2008.
The SILCS diaphragm, a new single-size barrier device
Partner: The Program for Appropriate Technology in Health (PATH)
An Investigational Device Exemption (IDE) was filed with the Food and Drug Administration to prepare for a contraceptive study with a new single-size barrier device, the SILCS diaphragm. A Phase III contraceptive trial, enrolling 450 couples in six U.S. sites, was initiated in January 2008.
Meloxicam, a non-steroidal, anti-inflammatory agent to be used in emergency contraception
Partner: Hewlett Foundation
Two studies were completed with the non-steroidal, anti-inflammatory agent meloxicam that have suggested it may improve the efficacy of levonorgestrel (LNG) when used for emergency contraception and that it may even be effective for that purpose when used alone. LNG is currently the main product used for emergency contraception and has a limited range of effectiveness (three days after unprotected sex). Meloxicam may expand the window of effectiveness and have fewer side effects. A new study, funded by the Hewlett Foundation, is exploring these possibilities in Santiago, Chile. The study is in analysis.
Cellulose sulfate as a contraceptive
Partner: Polydex Pharmaceuticals
A Phase II trial of 200 couples to test the contraceptive effectiveness of “Ushercell,” a gel containing 6% CS, was completed. The results showed that Ushercell was contraceptive with a six-month typical-use pregnancy probability of 13.4% and a “perfect-use” rate of 3.9%, which compares well with a recent study of the products currently on the market. More than three-quarters of the women and their partners in the study reported that they would buy Ushercell to prevent pregnancy.
Female condoms
Partner: PATH
CONRAD has continued its pioneer 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. CONRAD has supported PATH in the development of a new female condom known as the Woman's Condom since 1998. This new female condom has performed well with good acceptability in initial studies in the U.S. and South Africa. CONRAD is currently collaborating with the California Family Health Council on a study comparing the performance of the PATH Woman's Condom and the FC2 Female Condom. This study will compare self-reported clinical failure rates of the two condoms, and will also use vaginal detection of prostate-specific antigen (PSA) as an indicator of condom failure.