Contraception Clinical Trial
Official title:
A Randomized, Open Label Clinical Trial to Evaluate if Nestorone Gel Has Gonadotropin Suppressive Activity and if Nestorone in Combination With Testosterone Will Have an Additive Effect on Gonadotropin Suppression When Applied Transdermally in Healthy Men
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).
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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