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NCT01665599 · ClinicalTrials.gov registry record · Phase 3

A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel

A Phase 3 study of Adult Male Hypogonadism, sponsored by Ferring Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
180
Enrollment target
19
Study locations

NCT01665599: Completed Phase 3 study of Adult Male Hypogonadism, sponsored by Ferring Pharmaceuticals.

NCT01665599 is a Phase 3 study of Adult Male Hypogonadism that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 180 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). The trial reports 19 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01665599, a Phase 3 study of Adult Male Hypogonadism, has completed, sponsored by Ferring Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
180 participants
Enrollment target
19
Study locations

Study Summary

This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

Primary Outcome

The data were presented using descriptive statistics. No statistical analysis was performed.

Conditions Studied

Interventions

  • DRUG Testosterone gel (FE 999303)

Study Locations (19)

California

  • California Professional Research - Newport Beach
  • San Diego Sexual Medicine - San Diego

New York

  • University Urology - New York
  • Premier Medical Group of the Hudson Valley - Poughkeepsie

South Carolina

  • Coastal Carolina Research Center - Mt. Pleasant
  • Carolina Urologic Research Center - Myrtle Beach

Ontario

  • St. Joseph's Healthcare - London
  • Private Practice and Clinical Research - North Bay

Alabama

  • Medical Affiliated Research Cente - Huntsville

Connecticut

  • Connecticut Clinical Research - Middlebury

Florida

  • South Florida Medical Research - Aventura

Michigan

  • Michigan Institute of Urology - Saint Clair Shores

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2012-07
Est. Completion 2013-05
Phase Phase 3
Ferring Pharmaceuticals

83 total trials

What the finished NCT01665599 record still lists

NCT01665599 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).

The record links to 1 condition, with Adult Male Hypogonadism appearing as the primary indexed condition, and to 1 intervention - of which Testosterone gel (FE 999303) is the first listed.

NCT01665599 lists 19 locations in 15 states (California, New York, South Carolina).

Frequently Asked Questions

What is clinical trial NCT01665599 about?

NCT01665599 is a clinical study titled "A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel". This is a Phase 3 clinical trial in adult hypogonadal males with baseline serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the safety and efficacy of testosterone gel (2%) delivered using an applicator.

What is the current status of trial NCT01665599?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2012-07. Estimated completion is 2013-05.

What conditions does trial NCT01665599 study?

This clinical trial studies the following conditions: Adult Male Hypogonadism.

What interventions are being tested in trial NCT01665599?

The interventions under investigation include: Testosterone gel (FE 999303) (DRUG).

Who is sponsoring clinical trial NCT01665599?

This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01665599 being conducted?

This trial has 19 study locations across Alabama, California, Connecticut, Florida, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01665599's enrollment target sits among peer trials

180 1422nd of 2000 higher than 564 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT01665599, the US trial registry maintained by the National Library of Medicine. NCT01665599 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.