Single Dose, Dose-Ranging Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
NCT02754687 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-10-31
Summary
The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.
Conditions
- Healthy Men
- Male Contraception
Interventions
- DRUG
-
Placebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients
- DRUG
-
11βmethyl nortestosterone dodecylcarbonate
Escalating doses of 100, 200, 400, and 800 mg 11β-MNTDC
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH - collaborator OTHER
-
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
collaborator OTHER -
Premier Research
lead OTHER
Principal Investigators
-
Christina Wang, MD · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
-
Stephanie Page, MD, PhD · University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-07-14
- Primary Completion
- 2017-01-23
- Completion
- 2017-06-05
Countries
- United States
Study Locations
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