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Study of Daily Application of Nestorone® (NES) and Testosterone (T) Combination Gel for Male Contraception

NCT03452111 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2025-02-18

No results posted yet for this study

Summary

The long term objective is to develop a gel to be used as a male contraceptive.

Conditions

  • Healthy
  • Men
  • Male Contraception

Interventions

DRUG

Nestorone + Testosterone Combination Gel

The combined gel is a transdermal treatment that will be applied daily for 52 weeks to a male subject's arms and shoulders. The formulation will be a hydro alcoholic gel. About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume.

Sponsors & Collaborators

  • Population Council

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Premier Research

    lead OTHER

Principal Investigators

  • Diana Blithe, PhD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2024-09-06
Completion
2024-09-06
FDA Drug
Yes

Countries

  • United States
  • Chile
  • Italy
  • Kenya
  • Sweden
  • United Kingdom
  • Zimbabwe

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452111 on ClinicalTrials.gov