Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03452111
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-08
First Post:
2018-02-23
Brief Title:
Study of Daily Application of Nestorone NES and Testosterone T Combination Gel for Male Contraception
Sponsor:
Health Decisions
Organization:
Health Decisions
Study Overview
Official Title:
Clinical Evaluation of Daily Application of Nestorone NES and Testosterone T Combination Gel for Male Contraception
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
None
Brief Summary:
The long term objective is to develop a gel to be used as a male contraceptive
Detailed Description:
This is a prospective phase IIb open label single arm multicenter study The study protocol consists of a screening phase lasting 4 to 8 weeks a suppression phase estimated up to 20 weeks a 52-week maintenanceefficacy phase and a 24-week estimated recovery phase
The study will involve approximately 420 couples recruited throughout the CCTN that meet eligibility criteria Approximately fifteen sites propose to enroll up to 420 couples about 30 to 60 couples per site with a goal of obtaining 200 couples completing the contraceptive efficacy phase of the study The study has four phases screening phase suppression phase efficacy phase and recovery phase with monthly visits to provide the male participants with the NEST gel to encourage adherence to monitor for possible side effects and to quantify semen parameters The female partner will be contacted monthly and come in for a visit every three months Male subjects will be treated and followed as outpatients along with their participating female partner
The study will involve approximately 420 couples recruited throughout the CCTN that meet eligibility criteria Approximately fifteen sites propose to enroll up to 420 couples about 30 to 60 couples per site with a goal of obtaining 200 couples completing the contraceptive efficacy phase of the study The study has four phases screening phase suppression phase efficacy phase and recovery phase with monthly visits to provide the male participants with the NEST gel to encourage adherence to monitor for possible side effects and to quantify semen parameters The female partner will be contacted monthly and come in for a visit every three months Male subjects will be treated and followed as outpatients along with their participating female partner
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None