At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
11βmethyl nortestosterone dodecylcarbonate 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single Dose, Dose-Ranging Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) in Healthy Men
In Brief
A Phase 1 clinical trial evaluating Placebo and 11βmethyl nortestosterone dodecylcarbonate for Healthy Men and Male Contraception. Completed, enrolled 12 participants across 2 sites.
Detailed Summary
The long term objective is to develop a new male hormone 11-β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC) as a male hormonal contraceptive.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Men, Male Contraception
CountriesUnited States
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJul 2016
Primary CompletionJan 2017
Study CompletionJun 2017
TodayJul 2026
First PostedApr 28, 2016
Enrollment StartJul 14, 2016
Primary CompletionJan 23, 2017
Study CompletionJun 5, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 10.2 years ago
Interventions
Placebodrug
Placebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients
11βmethyl nortestosterone dodecylcarbonatedrug
Escalating doses of 100, 200, 400, and 800 mg 11β-MNTDC