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

This study has been completed.
Sponsor:
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

June 29, 2011
August 31, 2012
June 2011
October 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01386606 on ClinicalTrials.gov Archive Site
Change in leuteinizing hormone (LH) after 6 weeks of continuous dosing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hypogonadism
  • Low Testosterone
  • Drug: enclomiophene citrate

    capsule oral

    1X a day 6 weeks

    Other Names:
    • Androxal
    • low testosterone therapy
  • Drug: Testosterone

    topical gel

    1X a day 6 weeks

    Other Names:
    • topical testosterone
    • testosterone gel
    • exogenous testosterone
  • Experimental: Androxal 6.25 mg
    Intervention: Drug: enclomiophene citrate
  • Experimental: Androxal 12 mg
    Intervention: Drug: enclomiophene citrate
  • Experimental: Androxal 25 mg
    Intervention: Drug: enclomiophene citrate
  • Active Comparator: AndroGel
    AndroGel 5G topical testosterone
    Intervention: Drug: Testosterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01386606
ZA-204
No
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Principal Investigator: Jolene Berg, MD Cetero Research, San Antonio
Repros Therapeutics Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP