Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism

NCT01619683 | Completed Phase 3

• 1 other identifier: ZA-303
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 17

Brief Summary

To determine the effects of 12 months of treatment with Androxal on bone mineral density in men with secondary hypogonadism.

Conditions

Effect of Treatment on Bone Mineral Density

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  Change in bome mineral density at the end of study compared to placebo

  52 weeks

Secondary Outcomes (1)

• Testosterone

  52 weeks

Study Arms (2)

Androxal

EXPERIMENTAL

Drug: enclomiphene citrate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

enclomiphene citrate DRUG

12.5 mg, 1 capsule, daily, oral. After 6 weeks of treatment, subjects will remain on 12.5 mg/day if their morning testosterone level is greater than 300 ng/dL. If a subject's testosterone is less than 300 ng/dL, the subject's dose will be increased to 25 mg/day

Also known as: Androxal

Androxal

Placebo DRUG

1 placebo capsule per day, oral

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight (BMI 25 to 42 kg/m2 inclusive, or BMI 23 to 42 inclusive in Asian subjects) males age 18 to 60 inclusive
• 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 \<300ng/dL measured twice on separate days. One of the two TT levels must be confirmed at baseline. Subjects who fail this criterion will be enrolled in the placebo group.
• LH \<9.4 mIU/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 or pelleted testosterone within 6 months prior to study (men currently on topical products may be enrolled in the study after a 7-day washout period)
• Use of 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 or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study
• Clinically significant abnormal findings at screening (Visit 1), based on the Investigator's assessment.
• A hematocrit \>54% or a hemoglobin \>17 g/dL
• Clinically significant abnormal laboratory findings at baseline (Visit 2), 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)
• Abnormal fundoscopy exam such as central retinal vein occlusion
• 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
• Subjects with a Z-score of \<2

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (17)

Unknown Facility

Mesa, Arizona, 85213, United States

Location

Unknown Facility

Phoenix, Arizona, 85050, United States

Location

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Tempe, Arizona, 85283, United States

Location

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Mission Viejo, California, 92691, United States

Location

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Newport Beach, California, 92663, United States

Location

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Rancho Cucamonga, California, 91730, United States

Location

Unknown Facility

Clearwater, Florida, 33761, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33308, United States

Location

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Jupiter, Florida, 33458, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

Miami Gardens, Florida, 33169, United States

Location

Unknown Facility

Henderson, Nevada, 89052, United States

Location

Unknown Facility

Lawrenceville, New Jersey, 08690, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Rochester, New York, 14609, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Related Links

• Sponsor's corporate web page

MeSH Terms

Interventions

Enclomiphene

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 14, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

US (17)