To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

July 22, 2015 updated by: Repros Therapeutics Inc.

A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • University Urology Associates
      • Purchase, New York, United States, 10577
        • MAZE Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
  • Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Exclusion Criteria:

  • A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
  • Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
  • Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease.
  • Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25 mg Androxal no wash out
1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period
Drug: 25 mg Androxal
25 mg Androxal capsules, 1 capsule daily for 6 months
Other Names:
  • Enclomiphene citrate
Active Comparator: Testim 1% (topical testosterone)
Testim 1% Gel applied topically for 6 months
Drug: Testim 1%
Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
Other Names:
  • Topical testosterone
Experimental: 25 mg Androxal wash out
1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone
Drug: 25 mg Androxal
25 mg Androxal capsules, 1 capsule daily for 6 months
Other Names:
  • Enclomiphene citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm Concentration
Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Total sperm concentration was measured.
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Motile Total Sperm Count
Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Motile total sperm count was measured.
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Semen Volume
Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
Semen volume was measured.
Baseline, Month 3, Month 6, Follow-Up (Month 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Luteinizing Hormone (LH) Levels
Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
LH levels were measured.
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Follicle Stimulating Hormone (FSH) Levels
Time Frame: Baseline, Month 3, Month 6, Follow-Up (Month 7)
FSH levels were measured.
Baseline, Month 3, Month 6, Follow-Up (Month 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 27, 2008

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZA-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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