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| Sponsor: | Repros Therapeutics Inc. |
|---|---|
| Information provided by: | Repros Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT00706719 |
Purpose
To determine if Androxal® can correct the central defect in men who have AIHH that blocks their ability to produce the hormones (LH and FSH) which stimulate testosterone production and sertoli cell number, thereby restoring sperm count. Twelve subjects per group will be randomized to daily treatments of Androxal® or topical testosterone Testim ® for six months. These men must have been previously treated with exogenous testosterone.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility in Men Secondary Hypogonadism |
Drug: enclomiphene citrate Drug: topical testosterone gel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone. |
| Estimated Enrollment: | 24 |
| Study Start Date: | June 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
1 capsule daily of 25 mg of Androxal®
|
Drug: enclomiphene citrate
capsules, 25 mg, 1 capsule daily for 6 months
|
|
B: Active Comparator
Testim® 1% Gel
|
Drug: topical testosterone gel
gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months
|
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| University Urology Associates | |
| New York, New York, United States, 10016 | |
| MAZE Labs | |
| Purchase, New York, United States, 10577 | |
| Study Director: | Ronald Wiehle, PhD | Repros Therapeutics Inc. |
More Information
| Responsible Party: | Repros Therapeutics Inc. ( Ronald Wiehle, PhD ) |
| Study ID Numbers: | ZA-201 |
| Study First Received: | June 25, 2008 |
| Last Updated: | August 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00706719 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH) Secondary hypogonadism Semen volume Sperm count Sperm motility |
|
Infertility Gonadal Disorders Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Clomiphene Reproductive Control Agents Selective Estrogen Receptor Modulators Hormones Genital Diseases, Female Estrogen Receptor Modulators Neoplastic Processes Pathologic Processes Therapeutic Uses |
Neoplasm Metastasis Estrogen Antagonists Antineoplastic Agents, Hormonal Endocrine System Diseases Methyltestosterone Genital Diseases, Male Pharmacologic Actions Testosterone 17 beta-cypionate Testosterone Neoplasms Anabolic Agents Hypogonadism Fertility Agents, Female Fertility Agents Androgens |