A 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

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Acquired Hypogonadotropic Hypogonadism; Obesity

Treatments: Drug: Placebo; Drug: Enclomiphene

Study type: Interventional

Funder types: Industry

Identifiers

NCT02651688

ZA-205

Details and patient eligibility

About

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 testosterone (T) ≤300 ng/dL] following a 6 month diet and 15 month exercise program.

Full 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. Participants 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.

Enrollment: 50 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overweight (Body Mass Index (BMI) 30 to 42 (kg/m^2) inclusive) males age 18 to 60 inclusive.
• Waist circumference ≥ 40 inches (101.6 cm).
• Previously or concurrently diagnosed as having secondary hypogonadism.
• Must have 2 morning testosterone assessments at Visit 1, collected before 10 AM, 2-4 days apart, and both of which must be ≤ 300 (ng/dL).
• Luteinizing hormone (LH) >1.4 and < 9.4 milli International units per milliliter (mIU/mL) (at Visit 1 only).
• Glycated hemoglobin A1c (HbA1c) ≤7.5.
• Stable weight for last 3 months (+/- 10 pounds).
• Participant lives or works within 10 miles of the gym that will be used for the study.
• Must be fit enough to participate in the fitness program.
• Ability to complete the study in compliance with the protocol requirements.
• Ability to understand and provide written informed consent.

Exclusion criteria

• 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.
• Use of testosterone, Clomid, 5α-reductase inhibitors, human chorionic gonadotropin (hCG), androgen, estrogen, anabolic steroid, dehydroepiandrosterone (DHEA), or herbal hormone products during the study.
• Use of Clomid in the past year.
• Known hypersensitivity to Clomid.
• Allergy to soy, peanuts or latex.
• Chronic use of glucocorticoids (chronic use of inhaled or topical glucocorticoids is acceptable).
• History of drug abuse or chronic narcotic use including methadone.
• A recent history of alcoholism or illegal substance or steroid abuse (<2 years) or presence of moderate alcohol use (>21 drinks per week).
• 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.
• A hematocrit >54%.
• Presence or known history of hyperprolactinemia with or without a tumor (prolactin >20 ng/mL).
• Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a prostate specific antigen (PSA)>3.6.
• Current or history of breast cancer.
• Uncontrolled hypertension based on the Investigator's assessment at screening.
• History of bulimia nervosa or binge eating.
• Participant has (had) a lap band or undergone gastric bypass surgery.
• Participant has celiac disease or gluten intolerance.
• Participant has Type I diabetes.
• Participant 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.
• Enrolled and randomized (if applicable) in a previous enclomiphene study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 3 patient groups, including a placebo group

Enclomiphene 12.5 mg

Experimental group

Description:

Enclomiphene 12.5 milligram (mg) capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participant followed a commercial diet plan and exercised with a personal trainer at least 3 times a week.

Treatment:

Drug: Enclomiphene

Enclomiphene 25 mg

Experimental group

Description:

Enclomiphene 25 mg capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participant followed a commercial diet plan and exercised with a personal trainer at least 3 times a week.

Treatment:

Drug: Enclomiphene

Placebo

Placebo Comparator group

Description:

One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months. Participant followed a commercial diet plan and exercised with a personal trainer at least 3 times a week.

Treatment:

Drug: Placebo