Trial · Interventional
CompletedPhase 3Registry dataA Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 120 participants (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Jan 2014
- Primary completion
- Sept 2014
- Completion
- Sept 2014
- First posted
- 25 Nov 2013 (estimated)
- Last update posted
- 1 Oct 2014 (estimated)
- Conditions
- Secondary Hypogonadism
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
NCT01993212Jan 2014 to Sept 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
Interventions
- Androxal 12.5 mg or 25 mgDrug
- AndroGel 1.62%Drug
- Placebo CapsulesDrug
- Placebo GelDrug
Arms3
Placebo comparator
Placebo
Androxal Placebo and Gel Placebo
Active comparator
AndroGel Treatment
AndroGel 1.62% and Placebo Capsules
Experimental
Androxal Treatment
Androxal 12.5 mg or 25mg and Placebo Gel
Primary outcomes1
Outcomes the sponsor listed as primary.
Comparison of the proportion of subjects meeting the composite endpoint for normal morning testosterone and semen concentration.
Time frame · 16 weeks of treatment
Registry description
Comparison of the proportion of subjects whose morning testosterone levels are within the normal range \[300-1,040 ng/dL\] and whose sperm concentration is 15 million/mL or greater following 16 weeks of treatment with Androxal, placebo or AndroGel 1.62%.
Secondary outcomes(1)
Proportion of subjects with mean sperm concentration less than 15 million/mL after 16 weeks of treatment comparing Androxal to placebo in a non-inferiority assessment
Time frame · 16 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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