Overview

This trial is active, not recruiting.

Conditions acquired hypogonadotropic hypogonadism, obesity
Treatments placebo, 12.5 mg enclomiphene citrate, 25 mg enclomiphene citrate
Phase phase 2
Sponsor Repros Therapeutics Inc.
Start date January 2016
End date June 2017
Trial size 50 participants
Trial identifier NCT02651688, ZA-205

Summary

The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T≤300 ng/dL) following a 6 month diet and 15 month exercise program.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo
placebo
(Experimental)
12.5 mg Enclomiphene Citrate
12.5 mg enclomiphene citrate
(Experimental)
25 mg Enclomiphene Citrate
25 mg enclomiphene citrate

Primary Outcomes

Measure
Changes in Lean Body Mass (LBM), assessed using DXA
time frame: 12 months
Changes in waist circumference, comparing enclomiphene to placebo
time frame: 12 months
Changes from baseline in testosterone, comparing enclomiphene to placebo
time frame: 12 months
Values and changes in values from baseline in LH compared to placebo.
time frame: 12 months
Values and changes in values from baseline in HbA1c compared to placebo.
time frame: 12 months
Values and changes in values from baseline in FPG compared to placebo.
time frame: 12 months
Values and changes in values from baseline in high sensitivity C-reactive protein compared to placebo.
time frame: 12 months
Values and changes in values from baseline in Interleukin-6 compared to placebo.
time frame: 12 months
Values and changes in values from baseline in tumor necrosis factor (TNF-α) receptor 2 compared to placebo.
time frame: 12 months
Values and changes in values from baseline in leptin compared to placebo.
time frame: 12 months
Change in strength assessed from maximum chest and leg press weight achieved
time frame: 12 months
Changes in insulin resistance determined by Quantose IR™ (Metabolon Inc) compared to placebo
time frame: 12 months
Changes in insulin resistance determined by HOMA-IR compared to placebo
time frame: 12 months
Change in weight compared to placebo
time frame: 12 months
Change in BMI compared to placebo
time frame: 12 months
Values for dihydrotestosterone (DHT)
time frame: 12 months
Values for estradiol (E2)
time frame: 12 months
Values for ratios of DHT:testosterone
time frame: 12 months
Values for ratios of testosterone:E2
time frame: 12 months

Eligibility Criteria

Male participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Overweight (BMI 30 to 42 kg/m2 inclusive) males age 18 to 60 inclusive 2. Waist circumference ≥ 40 inches (101.6 cm) 3. Previously or concurrently diagnosed as having secondary hypogonadism. 4. Must have 2 morning testosterone assessments at Visit 1, collected before 10 AM, 2-4 days apart, and both of which must be ≤ 300ng/dL. 5. LH >1.4 and < 9.4 mIU/mL (at Visit 1 only) 6. HbA1c ≤7.5 7. Stable weight for last 3 months (+/- 10 pounds) 8. Lives or works within 10 miles of the gym that will be used for the study 9. Must be fit enough to participate in the fitness program 10. Ability to complete the study in compliance with the protocol requirements 11. Ability to understand and provide written informed consent Exclusion Criteria: 1. Any use of testosterone products (injectable, pelleted, transdermal or sublingual) in the 6 months prior to the study or any prior use of testosterone products for 12 months or longer at any time. 2. Use of testosterone, 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. Known hypersensitivity to Clomid 5. Allergy to soy, peanuts or latex 6. Chronic use of glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable) 7. History of drug abuse or chronic narcotic use including methadone 8. A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week) 9. 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 10. A hematocrit >54% 11. Presence or known history of hyperprolactinemia with or without a tumor (prolactin >20 ng/mL) 12. Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6 13. Current or history of breast cancer 14. Uncontrolled hypertension based on the Investigator's assessment at screening 15. History of bulimia nervosa or binge eating 16. Subject has (had) a lap band or undergone gastric bypass surgery 17. Subject has celiac disease or gluten intolerance 18. Subject has Type I diabetes 19. Subject has 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 20. Enrolled and randomized (if applicable) in a previous enclomiphene study

Additional Information

Official title A Randomized, Double Blind, Placebo-Controlled, Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
Description To compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T≤300 ng/dL) following a 6 month diet and 15 month exercise program. Subjects must not have been treated with testosterone products in the 6 months prior to the study and must not ever have used testosterone products for a year or longer.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Repros Therapeutics Inc..