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Trial record 16 of 51 for:    "Hypogonadism" | "Estrogens"

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

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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:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE June 25, 2008
First Posted Date  ICMJE June 27, 2008
Results First Submitted Date  ICMJE August 25, 2010
Results First Posted Date  ICMJE October 8, 2010
Last Update Posted Date August 19, 2015
Study Start Date  ICMJE June 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Secondary Hypogonadism
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2010)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2008)
24
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00706719
Other Study ID Numbers  ICMJE ZA-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Repros Therapeutics Inc.
Study Sponsor  ICMJE Repros Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald Wiehle, PhD Repros Therapeutics Inc.
PRS Account Repros Therapeutics Inc.
Verification Date July 2015

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