Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
This study has been completed.
Sponsor:
Repros Therapeutics Inc.
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01067365
First received: February 10, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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Purpose
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hypogonadism |
Drug: Androxal Drug: AndroGel Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism |
Resource links provided by NLM:
Drug Information available for:
Clomiphene citrate
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
Clomiphene
Sodium citrate
U.S. FDA Resources
Further study details as provided by Repros Therapeutics Inc.:
Primary Outcome Measures:
- Evaluate the safety of Androxal™ administered in men with secondary hypogonadism [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® [ Time Frame: Six months ] [ Designated as safety issue: No ]
| Enrollment: | 194 |
| Study Start Date: | March 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Androxal™
|
Drug: Androxal
12.5 mg once daily
Other Name: Enclomiphene citrate
|
|
Experimental: 2
Androxal™
|
Drug: Androxal
25 mg once daily
Other Name: Enclomiphene citrate
|
|
Active Comparator: 3
AndroGel®
|
Drug: AndroGel
5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert
|
|
Placebo Comparator: 4
Placebo
|
Drug: Placebo
1 capsule daily
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Total serum testosterone concentrations < 300 ng/dL at baseline
Exclusion Criteria:
- Presence or history of prostate cancer
- Elevated PSA > 3.5 ng/mL
Additional inclusion and exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067365
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics, LLC | |
| Birmingham,, Alabama, United States, 35235 | |
| Medial Affiliated Research Center, Inc. | |
| Huntsville, Alabama, United States, 35801 | |
| United States, California | |
| Northern California Research Corp | |
| Carmichael, California, United States, 95608 | |
| Prime-Care Clinical Research | |
| Mission Viejo, California, United States, 92691 | |
| Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| United States, Connecticut | |
| Chase Medical Research, LLC | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| Southeastern Research Group, Inc. | |
| Tallahassee,, Florida, United States, 32308 | |
| United States, Indiana | |
| Northeast Indiana Research, LLC | |
| Fort Wayne, Indiana, United States, 46825 | |
| United States, Kentucky | |
| Commonweatlh Biomedical Research | |
| Madisonville,, Kentucky, United States, 42431 | |
| United States, Maryland | |
| The Center for Sexual Medicine at Sheppard Pratt | |
| Baltimore, Maryland, United States, 21285 | |
| United States, Michigan | |
| Office of Keith Pierce, MD | |
| Livonia, Michigan, United States, 48152 | |
| United States, Nevada | |
| Office of Stephen Miller, MD | |
| Las Vegas, Nevada, United States, 89144 | |
| Office of Michael Mall, MD | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Advanced Biomedical Research, Inc. | |
| Hackensack, New Jersey, United States, 07601 | |
| Office of Gary S. Karlin, MD | |
| Lawrenceville, New Jersey, United States, 08648 | |
| United States, Tennessee | |
| Medical Research Associates of Nashville | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Urology San Antonio Research, PA | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Salt Lake Research | |
| Salt Lake City, Utah, United States, 84107 | |
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
| Study Director: | Andre van As, MD, PhD | Repros Therapeutics Inc. |
More Information
No publications provided
| Responsible Party: | Andre van As, MD, PhD, Repros Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01067365 History of Changes |
| Other Study ID Numbers: | ZA-003 Extension Study |
| Study First Received: | February 10, 2010 |
| Last Updated: | February 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Repros Therapeutics Inc.:
|
Secondary Hypogonadism |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Methyltestosterone Testosterone 17 beta-cypionate Testosterone Testosterone enanthate Testosterone undecanoate Clomiphene Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Anabolic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Androgens Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 16, 2013