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
  Purpose

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.


Condition Intervention Phase
Secondary Hypogonadism
Preservation of Reproductive Status
Drug: Placebo
Drug: topical testosterone
Drug: enclomiphene citrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 83
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo capsule 1x daily for 3 months
Active Comparator: Testim (topical testosterone) Drug: topical testosterone
testosterone gel applied 1x daily for 3 months
Other Names:
  • Testim
  • AndroGel
Experimental: Androxal 12.5 mg Drug: enclomiphene citrate
Capsule of either 12.5 mg or 25 mg, 1x daily for 3 months
Other Name: Androxal
Experimental: Androxal 25 mg Drug: enclomiphene citrate
Capsule of either 12.5 mg or 25 mg, 1x daily for 3 months
Other Name: Androxal

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270841

Locations
United States, California
Garden Grove, California, United States, 92844
Sacramento, California, United States, 95831
San Diego, California, United States, 92108
Torrance, California, United States, 90502
United States, Nevada
Las Vegas, Nevada, United States, 89109
Las Vegas, Nevada, United States, 89144
United States, New York
Great Neck, New York, United States, 11021
New York, New York, United States, 10022
Purchase, New York, United States, 10577
United States, Texas
Austin, Texas, United States, 78758
Carrollton, Texas, United States, 75010
Houston, Texas, United States, 77024
Houston, Texas, United States, 77062
Houston, Texas, United States, 77095
Houston, Texas, United States, 77030
Hurst, Texas, United States, 76054
Lake Jackson, Texas, United States, 77566
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Principal Investigator: Larry Lipshultz, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01270841     History of Changes
Other Study ID Numbers: ZA-203
Study First Received: January 4, 2011
Last Updated: August 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Clomiphene
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on April 14, 2014