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NCT02432261 · ClinicalTrials.gov registry record · Phase 1

Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men

A Phase 1 study of Healthy, sponsored by Kimberly Myer.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target
2
Study locations

NCT02432261: Completed Phase 1 study of Healthy, sponsored by Kimberly Myer.

NCT02432261 is a Phase 1 study of Healthy that has completed, run by Kimberly Myer. The registered enrollment target is 44 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02432261, a Phase 1 study of Healthy, has completed, sponsored by Kimberly Myer.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target
2
Study locations

Study Summary

This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.

Primary Outcome

To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \[LH\] and follicle-stimulating hormone \[FSH\]) to ≤ 1 IU/L in each group, will be quantified.

Conditions Studied

Healthy

Interventions

  • DRUG Nestorone® /testosterone gel
  • DRUG Testosterone only gel

Study Locations (2)

California

  • LA Biomedical Research Institute - Torrance

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2015-04
Est. Completion 2016-03
Phase Phase 1
Kimberly Myer

5 total trials

What the finished NCT02432261 record still lists

NCT02432261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Nestorone® /testosterone gel is the first listed.

NCT02432261 reports a single indexed study location in California, Washington.

Frequently Asked Questions

What is clinical trial NCT02432261 about?

NCT02432261 is a clinical study titled "Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men". This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.

What is the current status of trial NCT02432261?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2015-04. Estimated completion is 2016-03.

What conditions does trial NCT02432261 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT02432261?

The interventions under investigation include: Nestorone® /testosterone gel (DRUG), Testosterone only gel (DRUG).

Who is sponsoring clinical trial NCT02432261?

This trial is sponsored by Kimberly Myer, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02432261 being conducted?

This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02432261's enrollment target sits among peer trials

44 506th of 1090 higher than 570 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02432261, the US trial registry maintained by the National Library of Medicine. NCT02432261 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.