Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men
- Conditions
- HealthyMale ContraceptionMen
- Interventions
- Registration Number
- NCT03455075
- Lead Sponsor
- Health Decisions
- Brief Summary
This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to evaluate the spermatogenesis suppression after oral administration of Dimethandrolone Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.
- Detailed Description
This 12 week repeated dose study will be conducted at two centers: the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington. The sites propose to enroll approximately 100 men with a goal of enrolling 20 healthy male subjects in each of the 4 active groups and 20 in the placebo group for 12 weeks of treatment. The goal is to complete at least 17 efficacy evaluable subjects in each group. The DMAU for this study will be castor oil formulation administered after a 25 to 30 g fat meal. The oral dose of LNG will be 30 mcg per day. The study volunteers will be randomized to one of five treatment groups:
Group 1: Lower DMAU dose (100 mg per day) + LNG (30 mcg per day) (n=20) Group 2: Middle DMAU dose (200mg per day) + LNG (30 mcg per day) (n=20) Group 3: Middle DMAU dose (200 mg per day) + placebo LNG (n=20) Group 4: Higher DMAU dose (400 mg per day) + placebo LNG (n=20) Group 5: Placebo DMAU capsules and placebo LNG capsules (n=20)
Each treatment group will receive the identical number of capsules in blinded fashion so that each subject will receive an identical number of capsules in order to maintain the blind.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Higher DMAU + Placebo Placebo oral capsule DMAU 400 mg + placebo administered orally in capsules. Placebo Placebo oral capsule Placebo administered orally capsules. Lower DMAU + LNG Dimethandrolone-Undecanoate DMAU 100 mg + LNG 30 mcg administered orally in capsules. Lower DMAU + LNG Levonorgestrel 0.03 MG DMAU 100 mg + LNG 30 mcg administered orally in capsules. Middle DMAU + LNG Dimethandrolone-Undecanoate DMAU 200 mg + LNG 30 mcg administered orally in capsules. Middle DMAU + LNG Levonorgestrel 0.03 MG DMAU 200 mg + LNG 30 mcg administered orally in capsules. Middle DMAU + Placebo Dimethandrolone-Undecanoate DMAU 200 mg + placebo administered orally in capsules. Middle DMAU + Placebo Placebo oral capsule DMAU 200 mg + placebo administered orally in capsules. Higher DMAU + Placebo Dimethandrolone-Undecanoate DMAU 400 mg + placebo administered orally in capsules.
- Primary Outcome Measures
Name Time Method Suppression of spermatogenesis as assessed by semen analyses using number of subjects with sperm concentration <3 million (M)/mL with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks
- Secondary Outcome Measures
Name Time Method Changes from baseline in weight. 4 - 6 months Changes from baseline in blood pressure. 4 - 6 months Changes from baseline in heart rate. 4 - 6 months Changes from baseline in PSA with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in sperm concentration. 4 - 6 months Changes from baseline in blood urea nitrogen with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in Estradiol level. 4 - 6 months Changes from baseline in DHT level. 4 - 6 months Changes from baseline in LNG level. 4 - 6 months Incidence of treatment emergent adverse events (safety and tolerability) with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in potassium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in creatinine with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in calcium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in DMA level. 4 - 6 months Changes from baseline in sodium with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in bicarbonate with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in chloride with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Assessing suppression of gonadotropins using percentage of subjects with FSH and LH ≤ 1.0 IU/L. 2 months Changes from baseline in LH level. 4 - 6 months Changes from baseline in FSH level. 4 - 6 months Changes from baseline in Testosterone level. 4 - 6 months Changes from baseline in SHBG level. 4 - 6 months Changes from baseline in DMAU level. 4 - 6 months Changes from baseline in total bilirubin with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in fasting glucose with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in prostate function with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the International Prostate Symptom Score. 12 weeks Changes from baseline in mood with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the Patient Health Questionnaire-9. 12 weeks Changes from baseline in alkaline phosphatase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in alanine aminotransferase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in aspartate transaminase with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in albumin with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone. 12 weeks Changes from baseline in sexual function with daily oral dose of DMAU (3 different doses) alone or with LNG 30 mcg for 12 weeks versus placebo alone using the psychosexual daily questionnaire. 12 weeks
Trial Locations
- Locations (2)
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
University of Washington Medical Center & Health Sciences
🇺🇸Seattle, Washington, United States