A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
This study has been completed.
Sponsor:
Repros Therapeutics Inc.
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01386567
First received: June 29, 2011
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadism Low Testosterone |
Drug: Androxal (enclomiphene citrate) Drug: Testim (topical testosterone) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203 |
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:
- Change in testosterone comparing Androxal to Testim [ Time Frame: 1 year ] [ Designated as safety issue: No ]Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
Secondary Outcome Measures:
- Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim
- Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim
| Enrollment: | 48 |
| Study Start Date: | July 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Androxal
Androxal (enclomiphene citrate)12.5 mg or 25 mg
|
Drug: Androxal (enclomiphene citrate)
capsules oral 1x a day 1 year Other Name: enclomiphene citrate
|
| Active Comparator: Testim (topical testosterone) |
Drug: Testim (topical testosterone)
topical 1 tube 1x a day 1 year Other Names:
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Successful completion of ZA-203
- Ability to understand and provide written informed consent
- Agreement to use a condom, and with a fertile female partner, another form of contraception
- Agreement to provide semen samples in the clinic
Exclusion Criteria:
- Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386567
Locations
| United States, California | |
| Garden Grove, California, United States, 92844 | |
| Sacramento, California, United States, 95821 | |
| San Diego, California, United States, 92108 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89109 | |
| Las Vegas, Nevada, United States, 89144 | |
| United States, Texas | |
| Houston, Texas, United States, 77024 | |
| Houston, Texas, United States, 77095 | |
| Houston, Texas, United States, 77062 | |
Sponsors and Collaborators
Repros Therapeutics Inc.
More Information
Additional Information:
No publications provided
| Responsible Party: | Repros Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT01386567 History of Changes |
| Other Study ID Numbers: | ZA-203 Extension |
| Study First Received: | June 29, 2011 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Repros Therapeutics Inc.:
|
hypogonadism low testosterone low T |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Clomiphene Citric Acid Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents Anticoagulants Hematologic Agents Chelating Agents Molecular Mechanisms of Pharmacological Action 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 June 18, 2013