Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229593
Status:
COMPLETED
Last Update Posted:
2014-12-04
First Post:
2005-09-27
Brief Title:
NES Gel-1 To Evaluate Nestorone Gel in Combination With Testosterone Gel
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NES-1
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN27500002 | None | None | None |
| 04-3792-D 02 | OTHER | UW Human Subjects Division | None |