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NCT01382069 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
A Phase 1 study of Male Contraception and Healthy Men, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT01382069: Completed Phase 1 study of Male Contraception and Healthy Men, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
NCT01382069 is a Phase 1 study of Male Contraception and Healthy Men that has completed, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01382069, a Phase 1 study of Male Contraception and Healthy Men, has completed, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU) as a male hormonal contraceptive. The study has two parts. The first is a dose escalating study in healthy to assess the safety and tolerability of single dose oral administration of DMAUin healthy men.(Completed) The second is to study the safety and tolerability of DMAU after 28 days of repeated daily dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral administration of DMAU.
Primary Outcome
Number of severe or serious adverse event fdter escalating single doses of Dimethandrolone Undecanoated in a single dose escalating study or after 28 days repeat dosing in healthy men
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dimethandrolone Undecanoate
Study Locations (2)
California
- Los Angeles Biomedical Research Institute - Torrance
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-03 |
| Est. Completion | 2017-05 |
| Phase | Phase 1 |
What the finished NCT01382069 record still lists
NCT01382069 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 2 conditions, with Male Contraception appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01382069 reports a single indexed study location in California, Washington.
Frequently Asked Questions
What is clinical trial NCT01382069 about?
NCT01382069 is a clinical study titled "Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men". The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU) as a male hormonal contraceptive. The study has two parts. The first is a dose escalating study in healthy to assess the safety and tolerability of single dose oral administration of DMAUin healthy men.(Comp...
What is the current status of trial NCT01382069?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2012-03. Estimated completion is 2017-05.
What conditions does trial NCT01382069 study?
This clinical trial studies the following conditions: Male Contraception, Healthy Men.
What interventions are being tested in trial NCT01382069?
The interventions under investigation include: Placebo (DRUG), Dimethandrolone Undecanoate (DRUG).
Who is sponsoring clinical trial NCT01382069?
This trial is sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, which has 55 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01382069 being conducted?
This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01382069's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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