Trial · Interventional
CompletedPhase 3Registry dataAssessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 300 participants (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Design
- Not randomized · Single masking
- Countries
1 country
United States
- Start
- Sept 2012
- Primary completion
- Sept 2014
- Completion
- Sept 2014
- First posted
- 14 Jun 2012 (estimated)
- Last update posted
- 1 Oct 2014 (estimated)
- Conditions
- Effect of Treatment on Bone Mineral Density
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism
NCT01619683Sept 2012 to Sept 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.
Interventions
- enclomiphene citrateDrug
- PlaceboDrug
Arms2
Experimental
Androxal
Placebo comparator
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Bone Mineral Density
Time frame · 52 weeks
Registry description
Change in bome mineral density at the end of study compared to placebo
Secondary outcomes(1)
Testosterone
Time frame · 52 weeks
Registry description
Changes of values from baseline in total morning Testosterone levels at week 52.
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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