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The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.
Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Androxal 6.25 mg | Experimental | Androxal 6.25 mg/day |
|
| Androxal 12.5 mg | Experimental | Androxal 12.5 mg/day |
|
| Androxal 25 mg | Experimental | Androxal 25 mg/day |
|
| AndroGel | Active Comparator | AndroGel 5G topical testosterone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androxal (enclomiphene citrate) | Drug | capsule oral 1X a day 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Average and Maximum Testosterone Concentration | The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Leuteinizing Hormone (LH) | Changes in morning LH after continuous dosing | Baseline, Week 2, Week 4, Week 6 |
| Change in Follicle Stimulating Hormone (FSH) | Changes in morning FSH after continuous dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. | The Cmax for plasma concentration. | Week 6 |
| Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. | The Tmax for plasma concentration. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jolene Berg, MD | Cetero Research, San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centex Research | Houston | Texas | 77062 | United States | ||
| Cetero Research |
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| Label | URL |
|---|---|
| Sponsor website | View source |
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Androxal 6.25 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
| FG001 | Androxal 12.5 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
| FG002 | Androxal 25 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
| FG003 | AndroGel | AndroGel 5G topical testosterone Testosterone: topical gel 1X a day 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis consisted of all subjects enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Androxal 6.25 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
| BG001 | Androxal 12.5 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 24 Hour Average and Maximum Testosterone Concentration | The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24. | ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure. | Posted | Mean | Standard Deviation | ng/dL | Baseline and Week 6 |
|
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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 | Androxal 6.25 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer L. Wike | Repros Therapeutics Inc. | 281-719-3402 | jwike@reprosrx.com |
Not provided
| 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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| Testosterone | Drug | topical gel 1X a day 6 weeks |
|
|
| Baseline, Week 2, Week 4, Week 6 |
| Week 6 |
| Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. | The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24). | Week 6 |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Subject incarcerated |
|
| Unable to draw PK |
|
| T levels too high |
|
| BG002 | Androxal 25 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
| BG003 | AndroGel | AndroGel 5G topical testosterone Testosterone: topical gel 1X a day 6 weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
enclomiphene citrate: capsule oral
1X a day 6 weeks
| OG002 | Androxal 25 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks |
| OG003 | AndroGel | AndroGel 5G topical testosterone Testosterone: topical gel 1X a day 6 weeks |
|
|
|
| Secondary | Change in Leuteinizing Hormone (LH) | Changes in morning LH after continuous dosing | ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, Week 2, Week 4, Week 6 |
|
|
|
|
| Post-Hoc | Morning Testosterone Correlated With Serial Testosterone. | 9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax. If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation. | All Androxal subjects with Week 6 serial testosterone measurements. | Posted | Number | Number of Subjects | Week 6 |
|
|
|
|
| Other Pre-specified | Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. | The Cmax for plasma concentration. | PK population | Posted | Mean | Standard Deviation | ng/mL | Week 6 |
|
|
|
| Secondary | Change in Follicle Stimulating Hormone (FSH) | Changes in morning FSH after continuous dosing | ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure. | Posted | Mean | Standard Deviation | mIU/mL | Baseline, Week 2, Week 4, Week 6 |
|
|
|
|
| Other Pre-specified | Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. | The Tmax for plasma concentration. | PK population | Posted | Mean | Standard Deviation | h | Week 6 |
|
|
|
| Other Pre-specified | Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. | The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24). | PK population | Posted | Mean | Standard Deviation | ng*h/mL | Week 6 |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Androxal 12.5 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks | 0 | 14 | 1 | 14 |
| EG002 | Androxal 25 mg | enclomiphene citrate: capsule oral 1X a day 6 weeks | 0 | 16 | 1 | 16 |
| EG003 | AndroGel | AndroGel 5G topical testosterone Testosterone: topical gel 1X a day 6 weeks | 0 | 14 | 4 | 14 |
| Defaecation urgency | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | Systematic Assessment |
|
| Allodynia | Nervous system disorders | Systematic Assessment |
|
| Aggression | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Libido increased | Psychiatric disorders | Systematic Assessment |
|
| Urinary hesitancy | Renal and urinary disorders | Systematic Assessment |
|
| Epididymal cyst | Reproductive system and breast disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights.
| 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 |
| Morning LH at Week 2 |
|
| Morning LH Change from Baseline at Week 2 |
|
| Morning LH at Week 4 |
|
| Morning LH Change from Baseline at Week 4 |
|
| Morning LH at Week 6 |
|
| Morning LH Change from Baseline at Week 6 |
|
ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group. |
| ANOVA |
| <0.001 |
P-value for treatment group effect. |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group. | ANOVA | <0.001 | P-value for treatment group effect. | 2-Sided | No | Superiority or Other |
| t-test, 2 sided |
| <0.0001 |
| Pearson Correlation |
| 0.86541 |
| 2-Sided |
| No |
| Superiority or Other |
| Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6. | t-test, 2 sided | <0.0001 | Pearson Correlation | 0.89643 | 2-Sided | No | Superiority or Other |
| Morning FSH at Week 2 |
|
| Morning FSH Change from Baseline at Week 2 |
|
| Morning FSH at Week 4 |
|
| Morning FSH Change from Baseline at Week 4 |
|
| Morning FSH at Week 6 |
|
| Morning FSH Change from Baseline at Week 6 |
|
ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group. |
| ANOVA |
| <0.001 |
P-value for treatment group effect. |
| 2-Sided |
| No |
| Superiority or Other |
| ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group. | ANOVA | <0.001 | P-value for treatment group effect. | 2-Sided | No | Superiority or Other |