A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01386567
First received: June 29, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.


Condition Intervention Phase
Hypogonadism
Low Testosterone
Drug: Androxal (enclomiphene citrate)
Drug: Testim (topical testosterone)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Change in testosterone comparing Androxal to Testim [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim


Secondary Outcome Measures:
  • Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Values of follicle stimulating hormone (FSH) and leuteinizing hormone (LH) at each visit comparing Androxal 12.5 and 25 mg to Testim

  • Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone) [ Time Frame: 1 year ] [ 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 baseline (Visit 1), month 4, 6 and 12 comparing Androxal 12.5 and 25 mg to Testim


Enrollment: 48
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Androxal
Androxal (enclomiphene citrate)12.5 mg or 25 mg
Drug: Androxal (enclomiphene citrate)

capsules oral 1x a day

1 year

Other Name: enclomiphene citrate
Active Comparator: Testim (topical testosterone) Drug: Testim (topical testosterone)

topical

1 tube

1x a day

1 year

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

  Eligibility

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

Inclusion Criteria:

  • Successful completion of ZA-203
  • 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 semen samples in the clinic

Exclusion Criteria:

  • Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386567

Locations
United States, California
Garden Grove, California, United States, 92844
Sacramento, California, United States, 95821
San Diego, California, United States, 92108
United States, Nevada
Las Vegas, Nevada, United States, 89109
Las Vegas, Nevada, United States, 89144
United States, Texas
Houston, Texas, United States, 77024
Houston, Texas, United States, 77095
Houston, Texas, United States, 77062
Sponsors and Collaborators
Repros Therapeutics Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01386567     History of Changes
Other Study ID Numbers: ZA-203 Extension
Study First Received: June 29, 2011
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
hypogonadism
low testosterone
low T

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Clomiphene
Enclomiphene
Zuclomiphene
Citric Acid
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Anticoagulants
Hematologic Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Fertility Agents, Female

ClinicalTrials.gov processed this record on September 18, 2014