Clinical trial NCT02651688: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acquired Hypogonadotropic Hypogonadism
Obesity
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Lean Body Mass (LBM) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Body Strength (Chest Press Weight) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Body Strength (Leg Press Weight) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Testosterone (T) Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Estradiol (E2) Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Glucose Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Leptin Level at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Body Mass Index (BMI) at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Waist Circumference at Week 48
timeFrame: Baseline (Day 0) to Week 48
measure: Change From Baseline in Weight at Week 48
timeFrame: Baseline (Day 0) to Week 48
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Providence
country: United States
state: Rhode Island
city: Riverton
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References: