Male Birth Control Gel Study
Paid research study seeking healthy couples
Listen to our CureTalks interview to learn more about the study: https://www.curetalks.com/expanding-male-contraceptive-options-study-investigating-a-new-contraceptive-gel/
The Women's Health Clinical Research Center at University of Pennsylvania is currently recruiting healthy couples for a research study of an investigational birth control gel for men. The birth control gel being used in this research study is investigational. An "investigational" drug is an experimental drug that has not yet been approved by the Food and Drug Administration (FDA) to be sold in the United States. This gel is currently being developed to prevent pregnancy. The gel, a daily application of Nestorone and Testosterone, is a combined birth control gel that contains two types of hormones: Nestorone (8 mg/day) and testosterone (62mg/day). The male partner applies it daily and it works by suppressing sperm production. A pregnancy cannot happen in the absence of sperm.
Current birth control options available to men are limited to vasectomy and condoms. No safe, highly effective, reversible method is currently available to men who are interested in sharing the responsibility of family planning. The purpose of this research is to test how well the gel works to prevent pregnancy and which side effects it causes.
If you agree to participate in the study, you will take part in this research for about 2 years. The screening phase of the study lasts 4 to 8 weeks, the suppression phase of the study is estimated up to 20 weeks, the maintenance/efficacy phase is 52 weeks and the recovery phase is estimated at 24 weeks. During this time, the male partner will use the study drug for around 72 weeks and will visit the clinic every two to four weeks (minimum 32 clinic visits) for the 104 weeks of the study. In addition, the female partner will have phone visits monthly and a minimum of 10 clinic visits.
The study will involve physical exams, semen analysis, vital sign assessments, blood tests, pregnancy tests, urinalysis, STD tests and several questionnaires. In addition, male partners will be asked about their complete medical history and female partners will be asked for gynecological and menstrual history. Participants need to be sexually active and be willing to use the study gel as their only method of birth control during their participation in the study.
Participation in this study involves:
• visits to the study site and study phone calls
• physical exams
• blood and urine sampling
• semen collection
• using the investigational gel daily
The benefits of the trial for the participating couples include the use of a contraceptive agent during the effectiveness phase and contributing to the development of a reversible and effective male contraceptive. However, both members of the couple must be willing to accept a low but unknown risk of pregnancy for the duration of the trial.
If you are interested in participating in this study, complete the online pre-screener here or contact 215.662.7727 for more information