The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
This study has been completed.
Sponsor:
Repros Therapeutics Inc.
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01386606
First received: June 29, 2011
Last updated: August 31, 2012
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypogonadism Low Testosterone |
Drug: enclomiophene citrate Drug: Testosterone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men (and/or Men With Secondary Hypogonadism Not Currently on Testosterone Therapy) With Morning Testosterone ≤ 350 ng/dL Following Administration of the Drug for Six Weeks |
Resource links provided by NLM:
Drug Information available for:
Clomiphene citrate
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
Clomiphene
U.S. FDA Resources
Further study details as provided by Repros Therapeutics Inc.:
Primary Outcome Measures:
- 24 hour average and maximum testosterone concentration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. A regression analysis will be performed to determine whether testosterone levels assessed between 8 and 10 AM in the morning are predictive of TTmax and TTavg for the Androxal doses.
Secondary Outcome Measures:
- Change in leuteinizing hormone (LH) after 6 weeks of continuous dosing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | June 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Androxal 6.25 mg |
Drug: enclomiophene citrate
capsule oral 1X a day 6 weeks Other Names:
|
| Experimental: Androxal 12 mg |
Drug: enclomiophene citrate
capsule oral 1X a day 6 weeks Other Names:
|
| Experimental: Androxal 25 mg |
Drug: enclomiophene citrate
capsule oral 1X a day 6 weeks Other Names:
|
|
Active Comparator: AndroGel
AndroGel 5G topical testosterone
|
Drug: Testosterone
topical gel 1X a day 6 weeks Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
- All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
- Ability to complete the study in compliance with the protocol
- 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 a semen sample in the clinic
Exclusion Criteria:
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
- Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year or during the study
- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
- A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
- Clinically significant abnormal findings on screening examination
- Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
- Known hypersensitivity to Clomid
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
- Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
- History of breast cancer
- History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA >3.6
- History of known hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- Chronic use of narcotics
- Subjects known to be positive for HIV
- Subjects with end stage renal disease
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Subjects unable to provide a semen sample in the clinic
- Subject has a BMI >42 kg/m2
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386606
Locations
| United States, Texas | |
| Houston, Texas, United States, 77062 | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
| Principal Investigator: | Jolene Berg, MD | Cetero Research, San Antonio |
More Information
Additional Information:
Spronsor website 
Related Info 
No publications provided
| Responsible Party: | Repros Therapeutics Inc. |
| ClinicalTrials.gov Identifier: | NCT01386606 History of Changes |
| Other Study ID Numbers: | ZA-204 |
| Study First Received: | June 29, 2011 |
| Last Updated: | August 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Clomiphene Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents 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 21, 2013