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The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01386606
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Secondary Hypogonadism Drug: Androxal (enclomiphene citrate) Drug: Testosterone Phase 2

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.

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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
Drug: Androxal (enclomiphene citrate)

capsule oral

1X a day 6 weeks

Other Names:
  • Androxal
  • low testosterone therapy

Experimental: Androxal 12.5 mg
Androxal 12.5 mg/day
Drug: Androxal (enclomiphene citrate)

capsule oral

1X a day 6 weeks

Other Names:
  • Androxal
  • low testosterone therapy

Experimental: Androxal 25 mg
Androxal 25 mg/day
Drug: Androxal (enclomiphene citrate)

capsule oral

1X a day 6 weeks

Other Names:
  • Androxal
  • low testosterone therapy

Active Comparator: AndroGel
AndroGel 5G topical testosterone
Drug: Testosterone

topical gel

1X a day 6 weeks

Other Names:
  • topical testosterone
  • testosterone gel
  • exogenous testosterone

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in Leuteinizing Hormone (LH) [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]
    Changes in morning LH after continuous dosing

  2. Change in Follicle Stimulating Hormone (FSH) [ Time Frame: Baseline, Week 2, Week 4, Week 6 ]
    Changes in morning FSH after continuous dosing

Other Outcome Measures:
  1. Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax. [ Time Frame: Week 6 ]
    The Cmax for plasma concentration.

  2. Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax. [ Time Frame: Week 6 ]
    The Tmax for plasma concentration.

  3. 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).

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01386606

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United States, Texas
Centex Research
Houston, Texas, United States, 77062
Cetero Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repros Therapeutics Inc.
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Principal Investigator: Jolene Berg, MD Cetero Research, San Antonio

Additional Information:
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Responsible Party: Repros Therapeutics Inc. 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
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
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