The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
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ClinicalTrials.gov Identifier: NCT01386606 |
Recruitment Status :
Completed
First Posted : July 1, 2011
Results First Posted : September 23, 2015
Last Update Posted : September 23, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Secondary Hypogonadism | Drug: Androxal (enclomiphene citrate) Drug: Testosterone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
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 |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | October 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Androxal 6.25 mg
Androxal 6.25 mg/day
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Drug: Androxal (enclomiphene citrate)
capsule oral 1X a day 6 weeks Other Names:
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Experimental: Androxal 12.5 mg
Androxal 12.5 mg/day
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Drug: Androxal (enclomiphene citrate)
capsule oral 1X a day 6 weeks Other Names:
|
Experimental: Androxal 25 mg
Androxal 25 mg/day
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Drug: Androxal (enclomiphene citrate)
capsule oral 1X a day 6 weeks Other Names:
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Active Comparator: AndroGel
AndroGel 5G topical testosterone
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Drug: Testosterone
topical gel 1X a day 6 weeks Other Names:
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- 24 Hour Average and Maximum Testosterone Concentration [ Time Frame: Baseline and Week 6 ]
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.
Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
- Change in Leuteinizing Hormone (LH) [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]Changes in morning LH after continuous dosing
- Change in Follicle Stimulating Hormone (FSH) [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]Changes in morning FSH after continuous dosing
- Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. [ Time Frame: Week 6 ]The Cmax for plasma concentration.
- Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. [ Time Frame: Week 6 ]The Tmax for plasma concentration.
- Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24. [ Time Frame: Week 6 ]The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386606
United States, Texas | |
Centex Research | |
Houston, Texas, United States, 77062 | |
Cetero Research | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Jolene Berg, MD | Cetero Research, San Antonio |
Additional Information:
Responsible Party: | Repros Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT01386606 History of Changes |
Other Study ID Numbers: |
ZA-204 |
First Posted: | July 1, 2011 Key Record Dates |
Results First Posted: | September 23, 2015 |
Last Update Posted: | September 23, 2015 |
Last Verified: | August 2015 |
Neoplasm Metastasis Hypogonadism Neoplastic Processes Neoplasms Pathologic Processes Gonadal Disorders Endocrine System Diseases Methyltestosterone Enclomiphene Clomiphene Zuclomiphene Testosterone Testosterone undecanoate Testosterone enanthate Testosterone 17 beta-cypionate |
Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Anabolic Agents Estrogen Antagonists Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators |