NCT03455075

Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of Spermatogenesis Suppression After Oral Administration of Dimethandrolone Undecanote (DMAU) Alone or With Levonorgestrel (LNG) for 12 Weeks Versus Placebo Alone in Normal Men

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Premier Research · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Men
• Male Contraception

Interventions

Type	Name	Description
DRUG	Dimethandrolone-Undecanoate	Single doses of DMAU in castor oil/benzyl benzoate administered in 100 mg capsules.
DRUG	Levonorgestrel 0.03 MG	Single doses of LNG administered in 30 mcg capsules.
DRUG	Placebo oral capsule	Placebo capsules that look like DMAU and LNG capsules but with no active ingredients.

Timeline

• Start date: 2018-04-16
• Primary completion: 2020-03-05
• Completion: 2020-03-05
• First posted: 2018-03-06
• Last updated: 2025-10-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study