ARLINGTON, Va., Jan. 26 /PRNewswire/ -- CONRAD is pleased to announce the results of the Phase II study carried out to evaluate Ushercell’s contraceptive effectiveness. Ushercell is a vaginal gel containing 6% cellulose sulfate, which is being developed to prevent pregnancy and sexually transmitted infections, including HIV. Previous clinical safety studies have shown Ushercell to be safe for use by women and their male sexual partners. Ushercell is also in clinical trials to assess its ability to prevent HIV, gonorrhea, and chlamydia infections.
The chance of pregnancy in 6 months among typical users of Ushercell was 13.4%. The chance of pregnancy in 6 menstrual cycles of perfect use of Ushercell was 3.9%.
These figures compare very well with pregnancy probabilities for nonoxynol-9 (N-9), the only vaginal contraceptive drug marketed in the United States. In a recent study, N-9 gels had 6-month typical use pregnancy probabilities ranging from 14.0 to 22.2%, depending on the dose of N-9, and 6- cycle perfect use probabilities ranged from 8.5 to 15.7%.
“The data results are very promising. With its strong safety profile and these encouraging efficacy results, we remain confident in our development plan for Ushercell,” said Henry Gabelnick, Ph.D., executive director of CONRAD.
The primary objectives of this trial were to estimate the probability of pregnancy for six months of typical use and six menstrual cycles of perfect use of Ushercell. In addition, the study evaluated acceptability, consistency of use, and adverse events related to the use of Ushercell. It was a Phase II non-comparative contraceptive effectiveness trial, which enrolled 200 couples who agreed to use Ushercell vaginal gel as their primary means of contraception for six months. The study was sponsored by CONRAD and carried out by the California Family Health Council, Inc.
Over three quarters of the women and their partners reported that they would buy Ushercell to prevent pregnancy. Ushercell was used alone and correctly in over three-quarters of coital acts in the study. Only 1% of participants in the study were lost to follow-up, an unusually low figure, which allows a high level of confidence in the study results.
CONRAD is a cooperating agency of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases. CONRAD is administered through the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA, with the main office located in Arlington, VA. http://www.conrad.org
Polydex Pharmaceuticals Limited, based in Toronto, Ontario, Canada, is engaged in the research, development, manufacture and marketing of biotechnology-based products for the human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry. http://www.Polydex.com.
CONRAD
CONTACT: Annette Larkin for CONRAD, +1-202-429-4929, orannettelarkin@rationalpr.com; Investor Relations for PolydexPharmaceuticals Limited, Linda Hughes, North Arm Capital Services,+1-877-945-1621, or Linda@northarm.com
