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

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00706719
First received: June 25, 2008
Last updated: June 29, 2011
Last verified: June 2011

June 25, 2008
June 29, 2011
June 2008
July 2009   (final data collection date for primary outcome measure)
  • Mean Sperm Concentration Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Mean baseline values of total sperm concentration were measured for subjects in each of 3 treatment groups.
  • Mean Sperm Concentration 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean values of sperm concentration were measured for subjects in each of 3 treatment groups at 3 months
  • Mean Sperm Concentraion 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean values of sperm concentration were measured for subjects in each of 3 treatment groups at 6 months
  • Mean Total Sperm Count Basline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Mean values of total sperm count were measured for subjects in each of 3 treatment groups at baseline
  • Mean Total Sperm Count 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean values of total sperm count were measured for subjects in each of 3 treatment groups at 3 months
  • Mean Total Sperm Count 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean values of total sperm count were measured for subjects in each of 3 treatment groups at 6 months
  • Mean Semen Volume Baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Mean values of semen volume were measured for subjects in each of 3 treatment groups at baseline
  • Mean Semen Volume 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Mean values of semen volume were measured for subjects in each of 3 treatment groups at 3 months
  • Mean Semen Volume 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean values of semen volume were measured for subjects in each of 3 treatment groups at 6 months
Change in semen volume, sperm count and sperm motility from baseline in men treated with Androxal® [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00706719 on ClinicalTrials.gov Archive Site
Mean Follicle Stimulating Hormone(FSH) and Leutinizing Hormone(LH) Levels From Baseline to 3-months in Men Treated With Androxal® Versus Testim [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
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. 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infertility in Men
  • Secondary Hypogonadism
  • Drug: Androxal (enclomiphene citrate)
    capsules, 25 mg, 1 capsule daily for 6 months
  • Drug: topical testosterone gel
    gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
  • Experimental: Androxal (enclomiphene citrate) 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: Androxal (enclomiphene citrate)
  • Active Comparator: Testim (topical testosterone)
    Testim® 1% Gel applied topically for 6 months
    Intervention: Drug: topical testosterone gel
  • Experimental: Androxal (enclomiphene citrate) wash out
    1 x 25 mg capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone
    Intervention: Drug: Androxal (enclomiphene citrate)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
August 2009
July 2009   (final data collection date for primary outcome measure)

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
Male
21 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00706719
ZA-201
No
Ronald Wiehle, PhD, Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Study Director: Ronald Wiehle, PhD Repros Therapeutics Inc.
Repros Therapeutics Inc.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP