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NCT02994602 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Healthy Women and Male Contraception, sponsored by Kimberly Myer.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 2
- Study locations
NCT02994602: Completed Phase 1 study of Healthy Women and Male Contraception, sponsored by Kimberly Myer.
NCT02994602 is a Phase 1 study of Healthy Women and Male Contraception that has completed, run by Kimberly Myer. The registered enrollment target is 26 participants, below the 58-participant average among 4 other Healthy Women trials with a reported enrollment target (55% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02994602, a Phase 1 study of Healthy Women and Male Contraception, has completed, sponsored by Kimberly Myer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Evaluate in female participants by assessing changes from baseline up to 48 hours for serum testosterone levels in Cavg after secondary exposure to Nestorone + Testosterone Combination Gel summarized for each of the 3 types of skin contact between the man and woman.
Conditions Studied
Interventions
- DRUG Nestorone + Testosterone Combination Gel
Study Locations (2)
California
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Torrance
Washington
- University of Washington Medical Center & Health Sciences - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-01 |
| Est. Completion | 2017-10 |
| Phase | Phase 1 |
What the finished NCT02994602 record still lists
NCT02994602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 58-participant average among 4 other Healthy Women trials with a reported enrollment target (55% lower).
The record links to 4 conditions, with Healthy Women appearing as the primary indexed condition, and to 1 intervention - of which Nestorone + Testosterone Combination Gel is the first listed.
NCT02994602 reports a single indexed study location in California, Washington.
Frequently Asked Questions
What is clinical trial NCT02994602 about?
NCT02994602 is a clinical study titled "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". 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 ...
What is the current status of trial NCT02994602?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-01. Estimated completion is 2017-10.
What conditions does trial NCT02994602 study?
This clinical trial studies the following conditions: Healthy Women, Male Contraception, Healthy Men, Product Transference.
What interventions are being tested in trial NCT02994602?
The interventions under investigation include: Nestorone + Testosterone Combination Gel (DRUG).
Who is sponsoring clinical trial NCT02994602?
This trial is sponsored by Kimberly Myer, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02994602 being conducted?
This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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