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

An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

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

Study Overview

• Status: Completed
• Conditions: Secondary Hypogonadism
• Intervention / Treatment: Drug: Androxal

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.

• Study Type: Interventional
• Enrollment (Actual): 499
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Clinical Research Advantage
    • Phoenix, Arizona, United States, 85020
      • Clinical Research Advantage
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Chino, California, United States, 91710
      • Catalina Research Institute
    • Garden Grove, California, United States, 92844
      • SC Clinical Research
    • Laguna Hills, California, United States, 92653
      • South Orange County Endocrinology
    • Los Angeles, California, United States, 90069
      • Anthony Mills, MD
    • San Diego, California, United States, 92120
      • San Diego Sexual Medicine
    • San Diego, California, United States, 92103
      • SD Uro-Research
    • Santa Ana, California, United States, 92703
      • SC Clinical Research
    • Tarzana, California, United States, 91356
      • West Coast Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Clinical Research Advantage
    • Colorado Springs, Colorado, United States, 80922
      • Clinical Research Advantage
  • Florida
    • Bradenton, Florida, United States, 34208
      • Meridien Research
    • Clearwater, Florida, United States, 33759
      • Florida Fertility Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Therafirst Medical Center
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Clinical Research
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research
    • Jacksonville, Florida, United States, 32258
      • East Coast Institute for Research
    • Miami, Florida, United States, 33143
      • Well Pharma Medical Research
    • Miami Gardens, Florida, United States, 33169
      • Cetero Research
    • Pinellas Park, Florida, United States, 33782
      • DMI Research
    • Plantation, Florida, United States, 33324
      • Ebon Bourne, MD
    • St. Petersburg, Florida, United States, 33709
      • Meridien Research
  • Maryland
    • Towson, Maryland, United States, 21204
      • IRC Clinics
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Premier Urology Associates
  • Texas
    • Houston, Texas, United States, 77030
      • Advances in Health
    • Sugar Land, Texas, United States, 77479
      • Breco Research
    • Webster, Texas, United States, 77598
      • Center of Reproductive Medicine
  • Utah
    • Draper, Utah, United States, 84020
      • Lone Peak Family Medicine
    • Riverton, Utah, United States, 84065
      • Granger Medical Clin ic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Androxal 12.5 mg; Androxal 12.5 mg daily	Drug: Androxal; Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated; Other Names: Enclomiphene citrate
Experimental: Androxal 25 mg; Androxal 25 mg daily	Drug: Androxal; Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated; Other Names: Enclomiphene citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Morning Testosterone at 26 Weeks	Changes in values from baseline of total morning testosterone levels at Week 26	6 months
Change From Baseline in LH	Mean change from baseline in LH at end of treatment (26 weeks)	6 months
Absolute Values of Morning Testosterone	Absolute values of morning testosterone at end of treatment (26 weeks)	6 months
Mean Change From Baseline FPG	Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)	6 months
Change From Baseline in BMI	Mean change from baseline in BMI at end of treatment (26 weeks)	6 months
Change From Baseline in FSH	Change from baseline in FSH at end of treatment (26 weeks)	6 months

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Publications and helpful links

Helpful Links

• Sponsor home page

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: June 27, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Gonadal Disorders; Neoplastic Processes; Neoplasm Metastasis; Hypogonadism; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Clomiphene; Enclomiphene; Zuclomiphene
• Other Study ID Numbers: ZA-300