Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism (Low Testosterone), That Wish to Maintain Their Reproductive Status

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01270841
First received: January 4, 2011
Last updated: August 31, 2012
Last verified: August 2012

January 4, 2011
August 31, 2012
January 2011
December 2011   (final data collection date for primary outcome measure)
Change in Total Morning Testosterone [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Same as current
Complete list of historical versions of study NCT01270841 on ClinicalTrials.gov Archive Site
  • Change in Follicle Stimulating Hormone and Luteinizing Hormone Levels [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Changes in values from baseline in FSH and LH at months 1.5 and 3, comparing Androxal 12.5 and 25 mg to placebo and Testim
  • Measure of Safety Via Physical and Visual Acuity Examination, Slit Lamp Eye Exam, Clinical Laboratory Tests and Adverse Event Reporting [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Reproductive Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Reproductive safety will be assessed by changes in values from baseline of semen volume, and sperm concentration, total count, morphology and motility at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Same as current
Not Provided
Not Provided
 
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism (Low Testosterone), That Wish to Maintain Their Reproductive Status
A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism With Confirmed Morning Testosterone Levels <250 ng/dL That Wish to Preserve Their Reproductive Status and Are Not Currently Being Treated With Topical Testosterone

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Secondary Hypogonadism
  • Preservation of Reproductive Status
  • Drug: Placebo
    Placebo capsule 1x daily for 3 months
  • Drug: topical testosterone
    testosterone gel applied 1x daily for 3 months
    Other Names:
    • Testim
    • AndroGel
  • Drug: enclomiphene citrate
    Capsule of either 12.5 mg or 25 mg, 1x daily for 3 months
    Other Name: Androxal
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Testim (topical testosterone)
    Intervention: Drug: topical testosterone
  • Experimental: Androxal 12.5 mg
    Intervention: Drug: enclomiphene citrate
  • Experimental: Androxal 25 mg
    Intervention: Drug: enclomiphene citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males between the ages of 21 and 65 years of age
  • All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
  • Previously or concurrently diagnosed as having secondary hypogonadism and confirmed morning testosterone <250ng/dL (two assessments at least 10 days apart)
  • Ability to complete the study in compliance with the protocol
  • Ability to understand and provide written informed consent
  • Agreement to use double barrier contraception if with a fertile female partner
  • Agreement to provide a semen sample in the clinic

Exclusion Criteria:

  • Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 6 months prior to study
  • Use of spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
  • Use of Clomid in the past year
  • 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
  • A hematocrit >50% 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
  • Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
  • 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)
  • Current or history of breast cancer
  • Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6
  • Presence or history of hyperprolactinemia with or without a tumor
  • Chronic use of medications use such as glucocorticoids
  • Subjects with cystic fibrosis (mutation of the CFTR gene)
  • Subjects unable to provide a semen sample in the clinic
  • Subject has a BMI >36 kg/m2
Male
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01270841
ZA-203
No
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Principal Investigator: Larry Lipshultz, MD Baylor College of Medicine
Repros Therapeutics Inc.
August 2012

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