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
  Purpose

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.


Condition Intervention Phase
Hypogonadism
Low Testosterone
Drug: enclomiophene citrate
Drug: Testosterone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Change in leuteinizing hormone (LH) after 6 weeks of continuous dosing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Androxal 6.25 mg Drug: enclomiophene citrate

capsule oral

1X a day 6 weeks

Other Names:
  • Androxal
  • low testosterone therapy
Experimental: Androxal 12 mg Drug: enclomiophene citrate

capsule oral

1X a day 6 weeks

Other Names:
  • Androxal
  • low testosterone therapy
Experimental: Androxal 25 mg Drug: enclomiophene citrate

capsule oral

1X a day 6 weeks

Other Names:
  • Androxal
  • low testosterone therapy
Active Comparator: AndroGel
AndroGel 5G topical testosterone
Drug: Testosterone

topical gel

1X a day 6 weeks

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01386606

Locations
United States, Texas
Houston, Texas, United States, 77062
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Principal Investigator: Jolene Berg, MD Cetero Research, San Antonio
  More Information

Additional Information:
No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01386606     History of Changes
Other Study ID Numbers: ZA-204
Study First Received: June 29, 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
Enclomiphene
Zuclomiphene
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 August 20, 2014