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NCT02160704
Androxal in Male Infertility
Phase 2, PHASE3 trial testing Enclomiphene citrate in Infertility. Withdrawn.
2 August 2016
Quick facts
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 22 September 2014 |
| Primary completion | 2 August 2016 |
| Estimated completion | 2 August 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Enclomiphene citrate — full drug profile →
- Placebo
Conditions studied
- Infertility — all drugs for Infertility →
Sponsor
Baylor College of Medicine
Who can join
Adults 18 to 35, male only, with Infertility. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02160704
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Baylor College of Medicine trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02160704 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Baylor College of Medicine
- Last refreshed: 11 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02160704.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing