Overview

Study of Serum Testosterone and Nestorone in Females After Secondary Exposure to Nestorone ® (NES) + Testosterone (T) Combined Gel Applied to Shoulders and Upper Arms in Males

Status:
Completed

Trial end date:
2017-10-01

Target enrollment:

Participant gender:

Summary

This is a two-center, open-label study conducted in healthy male and female volunteers at two academic research centers. The study will consist of three single applications of the Nestorone (NES) + testosterone (T) combined gel on the shoulders/upper arms of male participants followed 2 hours later by supervised skin contact by the non-dosed female participants on the application site on days 1, 8, and 15. Effect of Washing or Clothing Barrier to the Application will be assessed.

Phase:

Phase 1

Details

Lead Sponsor:

Health Decisions

Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Los Angeles Biomedical Research Institute
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Population Council
University of Washington

Treatments:

Methyltestosterone
ST 1435
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate