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

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Effect of Treatment on Bone Mineral Density
Interventions
DRUG

enclomiphene citrate

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

DRUG

Placebo

1 placebo capsule per day, oral

Trial Locations (17)

10016

New York

14609

Rochester

33143

Miami

33169

Miami Gardens

33308

Fort Lauderdale

33458

Jupiter

33761

Clearwater

77030

Houston

84124

Salt Lake City

85050

Phoenix

85213

Mesa

85283

Tempe

89052

Henderson

91730

Rancho Cucamonga

92663

Newport Beach

92691

Mission Viejo

08690

Lawrenceville

All Listed Sponsors
lead

Repros Therapeutics Inc.

INDUSTRY

NCT01619683 - Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism | Biotech Hunter | Biotech Hunter