drugset / Trial / NCT03455075
Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men
Phase 2
Completed
92 enrolled
Premier Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · collabUniversity of Washington · collab
RandomizedParallel-groupQuadruple-blindOther
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.
Timeline
- Start
- 2018-04-16
- Primary completion
- 2020-03-05
- Completion
- 2020-03-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dimethandrolone Undecanoate | Unknown | 100 mg | Oral |
| Subject | Dimethandrolone Undecanoate | Unknown | 200 mg | Oral |
| Subject | Dimethandrolone Undecanoate | Unknown | 400 mg | Oral |
| Subject | Levonorgestrel | Small molecule | 30 ug | Oral |
Indications
No indication recorded.