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

NCT01534208 | Completed Phase 3 Results

• 1 other identifier: ZA-300
• Study Type: interventional
• Target: 499
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Secondary Hypogonadism

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Androxal 12.5 mg

EXPERIMENTAL

Androxal 12.5 mg daily

Drug: Androxal

Androxal 25 mg

EXPERIMENTAL

Androxal 25 mg daily

Drug: Androxal

Interventions

Androxal DRUG

Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Also known as: Enclomiphene citrate

Androxal 12.5 mg; Androxal 25 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Secondary hypogonadal males between the ages of 18 and 65
• Men currently using topical testosterone products should wash-out for at least 7 days before Visit 1.
• 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 with morning testosterone level \< 350 ng/dL for men age \< 55 and \< 300ng/dl for men age 55-65
• LH \< 15mIU/mL (at Visit 1 only)
• Ability to complete the study in compliance with the protocol
• Ability to understand and provide written informed consent.

You may not qualify if:

• 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).
• Use testosterone injection, 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 based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study.
• A hematocrit ≥ 51% or a hemoglobin ≥ 17 g/dL
• Clinically significant abnormal findings on screening examination, based on the Investigator's assessment.
• 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, 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 known hyperprolactinemia with or without a tumor
• Chronic use of medications use such as glucocorticoids

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (31)

Clinical Research Advantage

Glendale, Arizona, 85306, United States

Location

Clinical Research Advantage

Phoenix, Arizona, 85020, United States

Location

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Catalina Research Institute

Chino, California, 91710, United States

Location

SC Clinical Research

Garden Grove, California, 92844, United States

Location

South Orange County Endocrinology

Laguna Hills, California, 92653, United States

Location

Anthony Mills, MD

Los Angeles, California, 90069, United States

Location

SD Uro-Research

San Diego, California, 92103, United States

Location

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

SC Clinical Research

Santa Ana, California, 92703, United States

Location

West Coast Clinical Research

Tarzana, California, 91356, United States

Location

Clinical Research Advantage

Colorado Springs, Colorado, 80906, United States

Location

Clinical Research Advantage

Colorado Springs, Colorado, 80922, United States

Location

Meridien Research

Bradenton, Florida, 34208, United States

Location

Florida Fertility Institute

Clearwater, Florida, 33759, United States

Location

Therafirst Medical Center

Fort Lauderdale, Florida, 33308, United States

Location

East Coast Institute for Clinical Research

Jacksonville, Florida, 32204, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32204, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32258, United States

Location

Well Pharma Medical Research

Miami, Florida, 33143, United States

Location

Cetero Research

Miami Gardens, Florida, 33169, United States

Location

DMI Research

Pinellas Park, Florida, 33782, United States

Location

Ebon Bourne, MD

Plantation, Florida, 33324, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

IRC Clinics

Towson, Maryland, 21204, United States

Location

Premier Urology Associates

Lawrenceville, New Jersey, 08648, United States

Location

Advances in Health

Houston, Texas, 77030, United States

Location

Breco Research

Sugar Land, Texas, 77479, United States

Location

Center of Reproductive Medicine

Webster, Texas, 77598, United States

Location

Lone Peak Family Medicine

Draper, Utah, 84020, United States

Location

Granger Medical Clin ic

Riverton, Utah, 84065, United States

Location

Related Links

• Sponsor home page

MeSH Terms

Conditions

Hypogonadism

Interventions

Enclomiphene

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clomiphene; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Jennifer Wike
• Organization: Repros Therapeutics Inc.

jwike@reprosrx.com

2817193402

Study Officials

• Joseph S Podolski

  Repros Therapeutics Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 16, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 24, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-06

Locations

US (31)