Trial · Interventional
WithdrawnPhase 2/3Registry dataAndroxal in Male Infertility
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: Difficult eligibility and lack of funding
Overview
- Status
- Withdrawn
- Phase
- Phase 2/3
- Enrollment
- 0 participants (actual)
- Sponsor
- Baylor College of Medicine · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- 22 Sept 2014
- Primary completion
- 2 Aug 2016
- Completion
- 2 Aug 2016
- First posted
- 11 Jun 2014 (estimated)
- Last update posted
- 11 Jul 2019
- Conditions
- Infertility
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is an exploratory, single center, randomized, parallel, double-blind placebo- and active-controlled trial in adult males ages 18 to 35 years of age who have male infertility of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of the men will receive a placebo (non-active pill) for 16 weeks. This study will last approximately 4 months and involve up to 7 visits. The purpose of this study is to determine the effect the Androxal on sperm production.
Interventions
- Enclomiphene citrateDrug
- PlaceboOther
Arms2
Experimental
Arm 1(IP)
Enclomiphene citrate capsules 25 mg 1x daily for 16 weeks
Placebo comparator
Arm 2 (Placebo)
Placebo capsule 1x daily for 16 weeks
Primary outcomes1
Outcomes the sponsor listed as primary.
Doubling of total motile sperm count
Time frame · 16 weeks
Secondary outcomes(3)
Morning hormone levels
Time frame · 16 weeks
Registry description
Assess changes in values from baseline of total morning testosterone, estrogen and dihydrotestosterone levels after 16 weeks of treatment with placebo or 25 mg Androxal
Changes in questionnaire responses
Time frame · 16 weeks
Registry description
Assess change from baseline to endpoint in Androgen Deficiency Aging Male (ADAM), International Prostate Symptom Score (I-PSS), Sexual health inventory in Male (SHIM) and psychosexual daily questionnaire (PDQ)
BMI
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.
A trial that is still running, or that stopped early, may post results later.
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 35 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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