Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161447
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2005-09-08
Brief Title:
Male Hormonal Contraceptive Development-ACY-5
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Male Hormonal Contraceptive Development Suppression of Spermatogenesis With the Addition of a Potent Antagonist Acyline to Testosterone and DMPA ACY-5
Status:
COMPLETED
Status Verified Date:
2008-09
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:
ACY-5
Brief Summary:
The purpose of this research study is to help in the development of male contraception birth control
Detailed Description:
The objective is to conduct a male contraceptive trial in which we will evaluate the suppressive effects of acyline when administered in combination with Testosterone T and the progestin depo-medroxyprogesterone acetate DMPA
We will be administering combinations of three drugs Testosterone T by gel Depot Medroxyprogesterone acetate DMPA and Acyline to see their effects on sperm production The TDMPAAcyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis
In prior studies with testosterone and DMPA these drug which are hormones have been found to be safe and to reversibly suppress sperm counts to zero in about 80 of men We hope to improve this to 100 of men by adding another drug Acyline
Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary DMPA is approved by the FDA for use as a female contraceptive The endpoint will be suppression of spermatogenesis to zero azoospermia by the end of the treatment phase
We will be administering combinations of three drugs Testosterone T by gel Depot Medroxyprogesterone acetate DMPA and Acyline to see their effects on sperm production The TDMPAAcyline combination will allow us to determine if the more rapid and complete gonadotropin suppression mediated by the early addition of a GnRH antagonist will accelerate and enhance suppression of spermatogenesis
In prior studies with testosterone and DMPA these drug which are hormones have been found to be safe and to reversibly suppress sperm counts to zero in about 80 of men We hope to improve this to 100 of men by adding another drug Acyline
Acyline is an GnRH antagonist which blocks the release of LH and FSH from the pituitary DMPA is approved by the FDA for use as a female contraceptive The endpoint will be suppression of spermatogenesis to zero azoospermia by the end of the treatment phase
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 |
|---|---|---|---|
| U54HD042454 | NIH | None | httpsreporternihgovquickSearchU54HD042454 |