Primary outcomeMean· Baseline, Month 3, Month 6, Follow-Up (Month 7)
Sperm Concentration
| Group | Value (millions sperm/mL) | Spread |
|---|---|---|
| Group A Testim | 0.54 | 0.74 |
| Group B Androxal no Wash Out | 72.8 | 92.7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataTo Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
NCTNCT00706719 (opens ClinicalTrials.gov in a new tab)Other idZA-201
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 17 participants (actual)
- Sponsor
- Repros Therapeutics Inc. · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Jun 2008
- Primary completion
- Jul 2009
- Completion
- Aug 2009
- First posted
- 27 Jun 2008 (estimated)
- Last update posted
- 19 Aug 2015 (estimated)
- Conditions
- Secondary Hypogonadism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010
- Ph 2
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
NCT00706719Jun 2008 to Aug 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- 25 mg AndroxalDrug
- Testim 1%Drug
Arms3
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
Active comparator
Testim 1% (topical testosterone)
Testim 1% Gel applied topically for 6 months
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
Primary outcomes3
Outcomes the sponsor listed as primary.
Sperm Concentration
Time frame · Baseline, Month 3, Month 6, Follow-Up (Month 7)
Registry description
Total sperm concentration was measured.
Motile Total Sperm Count
Time frame · Baseline, Month 3, Month 6, Follow-Up (Month 7)
Registry description
Motile total sperm count was measured.
Semen Volume
Time frame · Baseline, Month 3, Month 6, Follow-Up (Month 7)
Registry description
Semen volume was measured.
Secondary outcomes(2)
Luteinizing Hormone (LH) Levels
Time frame · Baseline, Month 3, Month 6, Follow-Up (Month 7)
Registry description
LH levels were measured.
Follicle Stimulating Hormone (FSH) Levels
Time frame · Baseline, Month 3, Month 6, Follow-Up (Month 7)
Registry description
FSH levels were measured.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· Baseline, Month 3, Month 6, Follow-Up (Month 7)
Motile Total Sperm Count
| Group | Value (millions sperm) | Spread |
|---|---|---|
| Group A Testim | 0.3 | 0.48 |
| Group B Androxal no Wash Out | 99.0 | 159.6 |
Primary outcomeMean· Baseline, Month 3, Month 6, Follow-Up (Month 7)
Semen Volume
| Group | Value (mL) | Spread |
|---|---|---|
| Group A Testim | 2.34 | 1.43 |
| Group B Androxal no Wash Out | 2.23 | 0.81 |
Secondary and other outcome results(2)
Secondary outcomeMean· Baseline, Month 3, Month 6, Follow-Up (Month 7)
Luteinizing Hormone (LH) Levels
| Group | Value (mIU/mL) | Spread |
|---|---|---|
| Group A Testim | 3.40 | 2.14 |
| Group B Androxal no Wash Out | 2.92 | 1.69 |
Secondary outcomeMean· Baseline, Month 3, Month 6, Follow-Up (Month 7)
Follicle Stimulating Hormone (FSH) Levels
| Group | Value (mIU/mL) | Spread |
|---|---|---|
| Group A Testim | 3.38 | 0.74 |
| Group B Androxal no Wash Out | 1.58 | 0.74 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group A Testim1% Testim gel applied daily | – | 0 / 5 | 0 / 5 |
| Group B Androxal no Wash Out25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months | – | 0 / 7 | 2 / 7 |
| Androxal Wash Out25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone | – | 0 / 5 | 4 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 21 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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