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Spots Global Cancer Trial Database for Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

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Trial Identification

Brief Title: Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

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

Study ID: NCT01739595

Study Description

Brief Summary: The purpose of ZA-302 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.

Detailed Description: Protocol ZA-302 is a randomized, double-blind, placebo-controlled multi-center Phase 3 study to evaluate normalization of morning testosterone levels in overweight men with acquired hypogonadotropic hypogonadism and normal baseline sperm concentrations. The study requires 10 to 12 clinic visits (2 for eye exams), and is approximately 4 to 5½ months in duration. Subjects will be treated for 12-18 weeks. At Visit 3 (Week 6) subjects who do not achieve morning T values ≥300 ng/dL will be up-titrated to 25 mg. Placebo subjects may be sham titrated. Up-titrated subjects will receive an additional 6 weeks of treatment (18 weeks total). A schedule of procedures and assessments is displayed in Section 4. The study will enroll up to 152 male subjects, up to 114 randomized to treatment with Androxal and up to 38 randomized to placebo, in a 3:1 ratio. Subjects must not have used any prior testosterone treatments within the last 6 months. Eligible subjects must have 2 consecutive assessments of morning T below 300 ng/dL and LH below 9.4 mIU/mL. They will provide 2 sperm samples at baseline, at least 2 days apart, another 2 after 12 weeks of treatment, and up-titrated subjects will provide an additional 2 samples at the end of treatment. After 12 weeks of treatment (V5) all subjects will undergo serial T assessment for determination of the Cavg. Safety assessments will include collection of adverse events, eye examinations, physical examinations and clinical laboratory assessments.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Coastal Clinical Research, Mobile, Alabama, United States

Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States

Rancho Cucamonga Clinical Trials, Rancho Cucamonga, California, United States

Meridien Research, Bradenton, Florida, United States

All Medical Research, Cooper City, Florida, United States

Clinical Research of South Florida, Coral Gables, Florida, United States

Phase One Solutions, Miami Gardens, Florida, United States

Central Kentucky Research Associates, Lexington, Kentucky, United States

Rochester Clinical Research, Rochester, New York, United States

Coastal Carolina Research Center, Mount Pleasant, South Carolina, United States

New Orleans Center for Clinical Research, Knoxville, Texas, United States

Lone Peak Family Medicine, Draper, Utah, United States

Granger Medical Clinic, Riverton, Utah, United States

Contact Details

Name: Joseph S Podolski

Affiliation: Repros Therapeutics Inc.

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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