Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01534208
First received: February 9, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.


Condition Intervention Phase
Secondary Hypogonadism
Low Testosterone
Drug: enclomiphene citrate
Drug: Testosterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Resource links provided by NLM:


Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Change in total morning testosterone from baseline to 6 months (26 weeks) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in values from baseline of total morning testosterone levels at Week 26 comparing Androxal to Axiron

  • Changes in follicle stimulating hormone and luteinizing hormone from baseline to 6 months (26 weeks) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in values from baseline in FSH and LH at each dosing visit comparing Androxal to Axiron

  • Absolute values of morning testosterone, follicle stimulating hormone, and luteinizing hormone [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in diabetic parameters from baseline to 6 months (26 weeks) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in HbA1c, fasting plasma glucose, and HOMA-IR

  • Change in subject weight from baseline to 6 months (26 weeks) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety Assessment at baseline versus 6 months (26 weeks) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Safety will be assessed by physical and visual acuity examinations, slit lamp eye examinations, clinical laboratory tests and adverse event reporting


Enrollment: 499
Study Start Date: May 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Androxal Drug: enclomiphene citrate
oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Other Name: Androxal
Experimental: Axiron Drug: Testosterone
topical testosterone product applied once daily per manufacturer's instructions. Dose may be increased per manufacturer's instructions if indicated.
Other Name: Axiron

Detailed Description:

This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

  Eligibility

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

Inclusion Criteria:

  1. Secondary hypogonadal males between the ages of 18 and 65
  2. Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
  3. All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
  4. Previously or concurrently diagnosed as having secondary hypogonadism and confirmed with morning testosterone level < 350 ng/dL for men age < 55 and < 300ng/dl for men age 55-65
  5. LH < 15mIU/mL (at Visit 1 only)
  6. Ability to complete the study in compliance with the protocol
  7. Ability to understand and provide written informed consent.

Exclusion Criteria:

  1. Use of an injectable pelleted testosterone within 6 months prior to study (men currently on topical testosterone products may be enrolled in the study after a 7-day washout period).
  2. Use testosterone injection, spironolactone, cimetidine, Clomid, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
  3. Use of Clomid in the past year
  4. Uncontrolled hypertension based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
  5. A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
  6. Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.
  7. 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.
  8. Known hypersensitivity to Clomid
  9. Symptomatic cataracts (nuclear sclerosis cataract or cortical cataract grade > 2 based on 0-4 scale or any trace of posterior subcapsular cataract)
  10. 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
  11. Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, or tumors of the pituitary)
  12. Current or history of breast cancer
  13. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA > 3.6
  14. Presence or history of known hyperprolactinemia with or without a tumor
  15. Chronic use of medications use such as glucocorticoids
  16. Chronic use of narcotics
  17. Subjects know to be positive for HIV
  18. End stage renal disease
  19. Subjects with cystic fibrosis (mutation of the CFTR gene)
  20. Enrollment in a previous Androxal study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534208

Locations
United States, Arizona
Glendale, Arizona, United States, 85306
Phoenix, Arizona, United States, 85020
United States, California
Garden Grove, California, United States, 92844
Laguna Hills, California, United States, 92653
Los Angeles, California, United States, 90069
San Diego, California, United States, 92103
Santa Ana, California, United States, 92703
Tarzana, California, United States, 91356
United States, Colorado
Colorado Springs, Colorado, United States, 80922
Colorado Springs, Colorado, United States, 80906
United States, Florida
Bradenton, Florida, United States, 34208
Clearwater, Florida, United States, 33759
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32258
Jacksonville, Florida, United States, 32204
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33143
Miami Gardens, Florida, United States, 33169
Pinellas Park, Florida, United States, 33782
Plantation, Florida, United States, 33324
St. Petersburg, Florida, United States, 33709
St. Petersburg, Florida, United States, 33701
United States, Maryland
Towson, Maryland, United States, 21204
United States, New Jersey
Lawrenceville, New Jersey, United States, 08648
United States, Texas
Houston, Texas, United States, 77030
Sugar Land, Texas, United States, 77479
Webster, Texas, United States, 77598
United States, Utah
Draper, Utah, United States, 84020
West Valley City, Utah, United States, 84120
Sponsors and Collaborators
Repros Therapeutics Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01534208     History of Changes
Other Study ID Numbers: ZA-300
Study First Received: February 9, 2012
Last Updated: October 22, 2013
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
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
Molecular Mechanisms of Pharmacological Action
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 17, 2014