CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 83 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Androxal 12.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01270841
NCT01270841Phase 2Completed
CompareCT.gov

A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

Repros Therapeutics Inc.·interventional·Posted Jan 5, 2011·Updated Jul 28, 2014

In Brief

A Phase 2 clinical trial evaluating Placebo, topical testosterone, and 1 other intervention for Secondary Hypogonadism. Completed, enrolled 83 participants across 18 sites.

Detailed Summary

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSecondary Hypogonadism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2011
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.5 years ago

Interventions

Placebodrug

Placebo capsule 1x daily for 3 months

topical testosteronedrug

testosterone gel applied 1x daily for 3 months

Androxaldrug

Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months