Phase 2
N=50
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
Acquired Hypogonadotropic Hypogonadism · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02651688 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Jun 2019
Primary outcome: Primary: Change From Baseline in Lean Body Mass (LBM) at Week 48 — 65.23; 65.60; 68.12; 3.14 kg — p=0.7103
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Enclomiphene (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Repros Therapeutics Inc.
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Lean Body Mass (LBM) at Week 48 |
65.23; 65.60; 68.12; 3.14; 2.40; 1.05 | 0.7103 |
| PRIMARY Change From Baseline in Body Strength (Chest Press Weight) at Week 48 |
169.00; 180.93; 151.50; 75.00; 76.90; 87.27 | 0.9302 |
| PRIMARY Change From Baseline in Body Strength (Leg Press Weight) at Week 48 |
466.06; 464.20; 580.86; 406.92; 323.80; 351.50 | 0.5095 |
| PRIMARY Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48 |
3.93; 3.41; 3.51; 2.40; 3.01; 0.83 | 0.2960 |
| PRIMARY Change From Baseline in Blood Testosterone (T) Level at Week 48 |
243.56; 218.24; 223.53; 173.81; 237.17; 43.33 | 0.0034 sig |
| PRIMARY Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48 |
18.78; 16.06; 15.73; 15.13; 20.75; 4.25 | 0.0146 sig |
| PRIMARY Change From Baseline in Blood Estradiol (E2) Level at Week 48 |
50.04; 48.43; 45.49; -3.00; 13.03; -11.46 | 0.1524 |
| PRIMARY Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48 |
5.26; 4.93; 5.21; 5.11; 2.89; 2.85 | 0.5873 |
| PRIMARY Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48 |
0.08; 0.08; 0.07; 0.01; 0.00; 0.00 | 0.4341 |
| PRIMARY Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48 |
5.56; 5.95; 5.77; -0.34; -0.54; -0.65 | 0.0220 sig |
| PRIMARY Change From Baseline in Blood Glucose Level at Week 48 |
98.39; 101.41; 97.93; -1.81; -5.25; -4.33 | 0.9074 |
| PRIMARY Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48 |
0.25; 0.35; 0.35; 0.06; -0.05; -0.15 | 0.2962 |
| PRIMARY Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48 |
2.23; 3.38; 2.75; 0.56; -0.21; -0.78 | 0.0450 sig |
| PRIMARY Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48 |
1.77; 1.93; 1.94; -0.63; -0.35; -0.70 | 0.8260 |
| PRIMARY Change From Baseline in Blood Leptin Level at Week 48 |
9.88; 16.55; 15.16; 1.14; 2.63; -2.27 | 0.1144 |
| PRIMARY Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48 |
4.88; 4.99; 4.74; -1.14; -0.75; -1.80 | 0.1546 |
| PRIMARY Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48 |
75.74; 76.50; 78.05; -3.96; -6.59; -6.50 | 0.5581 |
| PRIMARY Change From Baseline in Body Mass Index (BMI) at Week 48 |
35.45; 37.38; 38.05; -1.43; -2.29; -4.38 | 0.0168 sig |
| PRIMARY Change From Baseline in Waist Circumference at Week 48 |
115.34; 120.87; 123.96; -6.71; -6.52; -12.62 | 0.0992 |
| PRIMARY Change From Baseline in Weight at Week 48 |
114.13; 121.75; 124.58; -4.36; -6.15; -14.51 | 0.0139 sig |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT02651688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.