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

• ClinicalTrials.gov Identifier: NCT00706719
• Recruitment Status: Completed
• First Posted: June 27, 2008
• Results First Posted: October 8, 2010
• Last Update Posted: August 19, 2015
• Sponsor: Repros Therapeutics Inc.
• Information provided by (Responsible Party): Repros Therapeutics Inc.

Tracking Information

• First Submitted Date: June 25, 2008
• First Posted Date: June 27, 2008
• Results First Submitted Date: August 25, 2010
• Results First Posted Date: October 8, 2010
• Last Update Posted Date: August 19, 2015
• Study Start Date: June 2008
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2015)

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

• Original Primary Outcome Measures (submitted: June 25, 2008): Change in semen volume, sperm count and sperm motility from baseline in men treated with Androxal® [ Time Frame: Months 3 and 6 ]
• Change History: Complete list of historical versions of study NCT00706719 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 22, 2015)

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

• Original Secondary Outcome Measures (submitted: June 25, 2008): Change in semen volume, sperm count and sperm motility in men treated with Androxal® versus men treated with Testim® [ Time Frame: Months 3 and 6. ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
• Official Title: 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.
• Brief Summary: 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.
• 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
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Secondary Hypogonadism

Intervention

• Drug: 25 mg Androxal
  25 mg Androxal capsules, 1 capsule daily for 6 months
  Other Name: Enclomiphene citrate
• Drug: Testim 1%
  Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
  Other Name: Topical testosterone

Study Arms

• 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
  Intervention: Drug: 25 mg Androxal
• Active Comparator: Testim 1% (topical testosterone)
  Testim 1% Gel applied topically for 6 months
  Intervention: Drug: Testim 1%
• 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
  Intervention: Drug: 25 mg Androxal

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2010): 17
• Original Estimated Enrollment (submitted: June 25, 2008): 24
• Actual Study Completion Date: August 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 21 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00706719
• Other Study ID Numbers: ZA-201
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Repros Therapeutics Inc.
• Study Sponsor: Repros Therapeutics Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Ronald Wiehle, PhD; Repros Therapeutics Inc.

• PRS Account: Repros Therapeutics Inc.
• Verification Date: July 2015