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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 mg Androxal no wash out | Experimental | 1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period |
|
| Testim 1% (topical testosterone) | Active Comparator | Testim 1% Gel applied topically for 6 months |
|
| 25 mg Androxal wash out | Experimental | 1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25 mg Androxal | Drug | 25 mg Androxal capsules, 1 capsule daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sperm Concentration | Total sperm concentration was measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
| Motile Total Sperm Count | Motile total sperm count was measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
| Semen Volume | Semen volume was measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Luteinizing Hormone (LH) Levels | LH levels were measured. | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
| Follicle Stimulating Hormone (FSH) Levels | FSH levels were measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Wiehle, PhD | Repros Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Urology Associates | New York | New York | 10016 | United States | ||
| MAZE Labs |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A Testim (Topical Testosterone) | 1% Testim gel applied once daily |
| FG001 | Group B Androxal no Washout | 25 mg Androxal capsules once daily in men who have not previously washed out topical testosterone |
| FG002 | Group C Androxal With Wash Out | 25 mg capsules once daily in men who have previously had a 3 month wash out of topical testosterone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A Testim | 1% Testim gel applied daily |
| BG001 | Group B Androxal no Wash Out | 25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sperm Concentration | Total sperm concentration was measured. | Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study. | Posted | Mean | Standard Deviation | millions sperm/mL | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A Testim | 1% Testim gel applied daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Gastrointestinal | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Wiehle, PhD | Repros Therapeutics, Inc | 281.719.3406 | rwiehle@reprosrx.com |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D064695 | Enclomiphene |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D002996 | Clomiphene |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Testim 1% | Drug | Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months |
|
|
| Baseline, Month 3, Month 6, Follow-Up (Month 7) |
| Purchase |
| New York |
| 10577 |
| United States |
| BG002 | Group C Androxal Wash Out | 25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Motile Total Sperm Count | Motile total sperm count was measured. | Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study. | Posted | Mean | Standard Deviation | millions sperm | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
|
|
|
|
| Primary | Semen Volume | Semen volume was measured. | Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study. | Posted | Mean | Standard Deviation | mL | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
|
|
|
|
| Secondary | Luteinizing Hormone (LH) Levels | LH levels were measured. | Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
|
|
|
|
| Secondary | Follicle Stimulating Hormone (FSH) Levels | FSH levels were measured. | Subjects in Group A and B who completed the study. No analysis was performed for subjects in Group C because only 1 subject completed the study. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, Month 3, Month 6, Follow-Up (Month 7) |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Group B Androxal no Wash Out | 25 mg Androxal 1 capsule per day in men who have not previously washed out topical testosterone for 3 months | 0 | 7 | 2 | 7 |
| EG002 | Androxal Wash Out | 25 mg 1 capsule per day in men who have undergone a 3 month wash out period of topical testosterone | 0 | 5 | 4 | 5 |
| erythema | Eye disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| worsening depression | Psychiatric disorders | Non-systematic Assessment |
|
| blurred vision | Eye disorders | Non-systematic Assessment |
|
| vasomotor flushing | Vascular disorders | Non-systematic Assessment |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Month 6 |
|
| Follow-Up (Month 7) |
|
| 0.0067 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of Group A and B observed values at Month 6. | Wilcoxon (Mann-Whitney) | 0.10 | 2-Sided | No | Superiority or Other |
| Comparison of Group A and B observed values at Follow-up (Month 7). | t-test, 2 sided | 0.26 | 2-Sided | No | Superiority or Other |
| Month 6 |
|
| Follow-Up (Month 7) |
|
| 0.612 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of Group A and B observed values at Month 6. | t-test, 2 sided | 0.488 | 2-Sided | No | Superiority or Other |
| Comparison of Group A and B observed values at Follow-up (Month 7). | t-test, 2 sided | 0.054 | 2-Sided | No | Superiority or Other |
| Month 6 |
|
| Follow-Up (Month 7) |
|
| 0.013 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of Group A and B observed values at Month 6. | t-test, 2 sided | 0.004 | 2-Sided | No | Superiority or Other |
| Comparison of Group A and B observed values at Follow-up (Month 7). | t-test, 2 sided | 0.808 | 2-Sided | No | Superiority or Other |
| Month 6 |
|
| Follow-Up (Month 7) |
|
| 0.015 |
| 2-Sided |
| No |
| Superiority or Other |
| Comparison of Group A and B observed values at Month 6. | t-test, 2 sided | 0.003 | 2-Sided | No | Superiority or Other |
| Comparison of Group A and B observed values at Follow-up (Month 7). | t-test, 2 sided | 0.109 | 2-Sided | No | Superiority or Other |