The purpose of this study is to determine the usefulness of two transdermal gels to be used in the future development for a male contraceptive.
The success of hormonal male contraception depends on the near complete suppression of spermatogenesis without producing any untoward effects on libido or other androgen-dependent functions or any other adverse events. The treatment with androgen alone has geen shown to be highly effective in Asian men but less effective in non-Asian men in clinical trials. To increase the efficacy of androgen alone treatment on spermatogenesis, combined regimens of a progestin and an androgen have shown promising results. The steady-state delivery of a progestin and an androgen by transdermal gel application would be a user-friendly delivery method as compared to injectable or implant approaches. Nestorone (NES) is a synthetic progestin that does not have any androgenic and estrogenic activity and is not expected to have some of the undesirable side effects of other drugs. We propose to evaluate whether NES gel alone or in combination with T gel applied transdermally will result in more effective suppression of gonadotropins than NES or T gel applied alone in healthy men. Fifty healthy male subjects, age 18-50 will be enrolled at each center (2 sites).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
140
2 to 8 mg Nestorone gel daily for 3 weeks depending on treatment group assignment
100 mg Testosterone gel daily for 3 weeks
Harbor-UCLA Medical Center
Torrance, California, United States
University of Washington Medical Center
Seattle, Washington, United States
- To determine the gonadotropin suppressive activity of Nestorone (NES) Gel at two doses and T gel at one dose alone or in combination over a 3-week period. Serum levels of gonadotropins will be assessed in all subjects.
Time frame: 3 weeks
To determine the effects on serum levels of total and free testosterone and SHBG and measure serum levels of NES gel.
Time frame: 3 weeks
Safety measured laboratory evaluations, vitals, pre- and post treatment physical exam results and PSA levels
Time frame: 3 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.