Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
Public ClinicalTrials.gov record NCT01532414. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.
Study identification
- NCT ID
- NCT01532414
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 151 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2012 (Type not available)
- Primary completion
- Mar 2013 (Actual)
- Completion
- Mar 2013 (Actual)
- Last update posted
- May 27, 2015
2012 – 2013
United States locations
- U.S. sites
- 23
- U.S. states
- 11
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coastal Clinical Research | Mobile | Alabama | 36608 | — |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| SC Clinical Research | Garden Grove | California | 92844 | — |
| Mission Internal Medicine Group | Mission Viejo | California | 92691 | — |
| Rancho Cucamonga Clinical Trials | Rancho Cucamonga | California | 91730 | — |
| San Diego Sexual Medicine | San Diego | California | 92120 | — |
| West Coast Clinical Research | Tarzana | California | 91356 | — |
| Florida Fertility Institute | Clearwater | Florida | 33759 | — |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | — |
| ALL Medical Research | Cooper City | Florida | 33024 | — |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | — |
| Therafirst Medical Center | Fort Lauderdale | Florida | 33308 | — |
| Well Pharma Medical Research Group | Miami | Florida | 33143 | — |
| Phase One Solutions | Miami Gardens | Florida | 33169 | — |
| Meridien Research | St. Petersburg | Florida | 33709 | — |
| Central Kentucky Research Associates | Lexington | Kentucky | 40509 | — |
| Clinical Research Advantage | Henderson | Nevada | 89052 | — |
| Premier Urology Associates | Lawrenceville | New Jersey | 08648 | — |
| Rochester Clinical Research | Rochester | New York | 14609 | — |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | — |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | — |
| Lone Peak Family Medicine | Draper | Utah | 84020 | — |
| Granger Medical Clinic | West Valley City | Utah | 84120 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01532414, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2015 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01532414 live on ClinicalTrials.gov.