A 12 Month, Single Blind, Placebo Controlled, Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment On Bone Mineral Density in Men With Secondary Hypogonadism

Repros Therapeutics Inc.0 sites300 target enrollmentSeptember 2012

ConditionsEffect of Treatment on Bone Mineral Density

Interventionsenclomiphene citrate Placebo

Drugsenclomiphene citrate Placebo

Overview

Phase: Phase 3
Intervention: enclomiphene citrate
Conditions: Effect of Treatment on Bone Mineral Density
Sponsor: Repros Therapeutics Inc.
Enrollment: 300
Primary Endpoint: Bone Mineral Density
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Detailed Description

This study is a phase III single-blind placebo-controlled safety study with a 52 week active dosing period with Androxal. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy eye exams, clinical laboratory tests, DEXA scanning, lean soft tissue assessment (LST), and adverse event reporting. Results will be compared to an age-matched placebo group.

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

September 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Repros Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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)