Back to resultsTo Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Primary Purpose
Secondary Hypogonadism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
25 mg Androxal
Testim 1%
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hypogonadism focused on measuring Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH), Secondary hypogonadism, Semen volume, Sperm count, Sperm motility
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
Sites / Locations
- University Urology Associates
- MAZE Labs
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
25 mg Androxal no wash out
Testim 1% (topical testosterone)
25 mg Androxal wash out
Arm Description
1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period
Testim 1% Gel applied topically for 6 months
1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone
Outcomes
Primary Outcome Measures
Sperm Concentration
Total sperm concentration was measured.
Motile Total Sperm Count
Motile total sperm count was measured.
Semen Volume
Semen volume was measured.
Secondary Outcome Measures
Luteinizing Hormone (LH) Levels
LH levels were measured.
Follicle Stimulating Hormone (FSH) Levels
FSH levels were measured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00706719
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hypogonadism
Keywords
Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH), Secondary hypogonadism, Semen volume, Sperm count, Sperm motility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
25 mg Androxal no wash out
Arm Type
Experimental
Arm Description
1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period
Arm Title
Testim 1% (topical testosterone)
Arm Type
Active Comparator
Arm Description
Testim 1% Gel applied topically for 6 months
Arm Title
25 mg Androxal wash out
Arm Type
Experimental
Arm Description
1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone
Intervention Type
Drug
Intervention Name(s)
25 mg Androxal
Other Intervention Name(s)
Enclomiphene citrate
Intervention Description
25 mg Androxal capsules, 1 capsule daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Testim 1%
Other Intervention Name(s)
Topical testosterone
Intervention Description
Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
Primary Outcome Measure Information:
Title
Sperm Concentration
Description
Total sperm concentration was measured.
Time Frame
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Title
Motile Total Sperm Count
Description
Motile total sperm count was measured.
Time Frame
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Title
Semen Volume
Description
Semen volume was measured.
Time Frame
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Secondary Outcome Measure Information:
Title
Luteinizing Hormone (LH) Levels
Description
LH levels were measured.
Time Frame
Baseline, Month 3, Month 6, Follow-Up (Month 7)
Title
Follicle Stimulating Hormone (FSH) Levels
Description
FSH levels were measured.
Time Frame
Baseline, Month 3, Month 6, Follow-Up (Month 7)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Wiehle, PhD
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MAZE Labs
City
Purchase
State/Province
New York
ZIP/Postal Code
10577
Country
United States
12. IPD Sharing Statement
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To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
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