Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Testim (topical testosterone) | Active Comparator | Testim (topical testosterone) |
|
| Androxal 12.5 mg | Experimental | Androxal 12.5 mg/day |
|
| Androxal 25 mg | Experimental | Androxal 25 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo capsule 1x daily for 3 months |
| |
| topical testosterone |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Morning Testosterone | Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Luteinizing Hormone Levels | Changes in values from baseline in LH at month 3 | 3 months |
| Change in FSH After 3 Months of Treatment | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Larry Lipshultz, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paradigm Clinical Inc. | Garden Grove | California | 92844 | United States | ||
| Northern California Research Corp |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25044085 | Derived | Wiehle RD, Fontenot GK, Wike J, Hsu K, Nydell J, Lipshultz L; ZA-203 Clinical Study Group. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17. |
| Label | URL |
|---|---|
| Sponsor website | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo: Placebo capsule 1x daily for 3 months |
| FG001 | Testim (Topical Testosterone) | Testim (topical testosterone) topical testosterone: testosterone gel applied 1x daily for 3 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
testosterone gel applied 1x daily for 3 months |
|
|
| Androxal | Drug | Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months |
|
|
| Reproductive Safety | Change from baseline in sperm concentration | 3 months |
| Sacramento |
| California |
| 95831 |
| United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | United States |
| Affiliated Clinical Research | Las Vegas | Nevada | 89109 | United States |
| Affiliated Clinical Research Inc. | Las Vegas | Nevada | 89144 | United States |
| Weill Cornell Medical College and Smith Institute | Great Neck | New York | 11021 | United States |
| Jed Kaminetsky | New York | New York | 10016 | United States |
| Natan Bar-Chama | New York | New York | 10022 | United States |
| Michael A Werner | Purchase | New York | 10577 | United States |
| Discovery Clinical Trials | Austin | Texas | 78758 | United States |
| Research Across America | Carrollton | Texas | 75010 | United States |
| Texas Urology Specialist | Houston | Texas | 77024 | United States |
| Centex Research | Houston | Texas | 77062 | United States |
| Endocrine and Psychiatry Center | Houston | Texas | 77095 | United States |
| Protenium Clinical Research | Hurst | Texas | 76054 | United States |
| R/D Clinical Research | Lake Jackson | Texas | 77566 | United States |
| Cetero Research | San Antonio | Texas | 78229 | United States |
| Website | View source |
| FG002 | Androxal 12.5 mg | Androxal 12.5 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months |
| FG003 | Androxal 25 mg | Androxal 25 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: Placebo capsule 1x daily for 3 months |
| BG001 | Testim (Topical Testosterone) | Testim (topical testosterone) topical testosterone: testosterone gel applied 1x daily for 3 months |
| BG002 | Androxal 12.5 mg | Androxal 12.5 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months |
| BG003 | Androxal 25 mg | Androxal 25 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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/m2 |
|
| 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 | Change in Total Morning Testosterone | Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim | Intent to treat subjects with an assessment after baseline | Posted | Mean | Standard Deviation | ng/dL | 3 months |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Luteinizing Hormone Levels | Changes in values from baseline in LH at month 3 | ITT population | Posted | Mean | Standard Deviation | mIU/mL | 3 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change in FSH After 3 Months of Treatment | ITT population | Posted | Mean | Standard Deviation | mIU/mL | 3 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Reproductive Safety | Change from baseline in sperm concentration | Subjects with end of study assessments | Posted | Mean | Standard Deviation | millions/mL | 3 months |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo: Placebo capsule 1x daily for 3 months | 0 | 28 | 3 | 28 | ||
| EG001 | Testim (Topical Testosterone) | Testim (topical testosterone) topical testosterone: testosterone gel applied 1x daily for 3 months | 1 | 33 | 15 | 33 | ||
| EG002 | Androxal 12.5 mg | Androxal 12.5 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months | 0 | 27 | 3 | 27 | ||
| EG003 | Androxal 25 mg | Androxal 25 mg/day Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months | 0 | 33 | 3 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Subject was admitted to the hospital for high A1C level of 16.9. The PI assessed the event as moderate in intensity, and definitely not related to the study medication. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Addominal Pain Upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sperm concentration decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer L. Wike | Repros Therapeutics Inc. | 281-719-3402 | jwike@reprosrx.com |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D064695 | Enclomiphene |
| ID | Term |
|---|---|
| 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 |
| D002996 | Clomiphene |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
|
|
| Participants |
|
|