Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 10:00 PM
Study NCT ID:
NCT01382069
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2011-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Organization:
Study Overview
Official Title:
Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMAUPhase1
Brief 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.
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.
Detailed Description:
The study will be conducted in two centers.
28-Day Repeat-Dose, Dose-Escalation Study: Based on the safety and tolerability of the single dose study and serum DMA levels attained, three doses of two formulations of DMAU were selected for a dose-escalating 28-day repeat dose study. Safety will be assessed in subjects receiving lower dosages before additional men receive higher doses for 28 days. Up to 100 men will be randomized to receive either active drug or an identical number of capsules of placebo. The 24-hour detailed PK of DMA will be assessed on day 1 and 28. Trough levels of DMA will be obtained throughout the 28-day period and at 48 and 72 hours after the last dose. In addition to safety and tolerability, suppression of serum T, gonadotropins, and SHBG will also be assessed as secondary pharmacodynamic (PD) endpoints. Psychosexual diaries for 7 consecutive days and PHQ-9 (questionnaire)will be obtained before and at the end of the study period.
28-Day Repeat-Dose, Dose-Escalation Study: Based on the safety and tolerability of the single dose study and serum DMA levels attained, three doses of two formulations of DMAU were selected for a dose-escalating 28-day repeat dose study. Safety will be assessed in subjects receiving lower dosages before additional men receive higher doses for 28 days. Up to 100 men will be randomized to receive either active drug or an identical number of capsules of placebo. The 24-hour detailed PK of DMA will be assessed on day 1 and 28. Trough levels of DMA will be obtained throughout the 28-day period and at 48 and 72 hours after the last dose. In addition to safety and tolerability, suppression of serum T, gonadotropins, and SHBG will also be assessed as secondary pharmacodynamic (PD) endpoints. Psychosexual diaries for 7 consecutive days and PHQ-9 (questionnaire)will be obtained before and at the end of the study period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HHSN275201000080U | OTHER_GRANT | NICHD Contract. This is not a grant but a contract | View |