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Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

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.
ClinicalTrials.gov Identifier: NCT01270841
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Information provided by (Responsible Party):

January 4, 2011
January 5, 2011
June 18, 2014
July 28, 2014
July 28, 2014
January 2011
December 2011   (Final data collection date for primary outcome measure)
Change in Total Morning Testosterone [ Time Frame: 3 months ]
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 Luteinizing Hormone Levels [ Time Frame: 3 months ]
    Changes in values from baseline in LH at month 3
  • Change in FSH After 3 Months of Treatment [ Time Frame: 3 months ]
  • Reproductive Safety [ Time Frame: 3 months ]
    Change from baseline in sperm concentration
  • Change in Follicle Stimulating Hormone and Luteinizing Hormone Levels [ Time Frame: 3 months ]
    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 ]
  • Reproductive Safety [ Time Frame: 3 months ]
    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
Not Provided
Not Provided
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
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
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Secondary Hypogonadism
  • 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: Androxal
    Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
    Other Name: Enclomiphene citrate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Testim (topical testosterone)
    Testim (topical testosterone)
    Intervention: Drug: topical testosterone
  • Experimental: Androxal 12.5 mg
    Androxal 12.5 mg/day
    Intervention: Drug: Androxal
  • Experimental: Androxal 25 mg
    Androxal 25 mg/day
    Intervention: Drug: Androxal
Wiehle RD, Fontenot GK, Wike J, Hsu K, Nydell J, Lipshultz L; ZA-203 Clinical Study Group. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014 Sep;102(3):720-7. doi: 10.1016/j.fertnstert.2014.06.004. Epub 2014 Jul 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: Male
21 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Principal Investigator: Larry Lipshultz, MD Baylor College of Medicine
Repros Therapeutics Inc.
June 2014

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