CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Progesterone +1 moredrug
Likely dose
Not stated in 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.

Search/NCT01798394
NCT01798394N/ACompleted
CompareCT.gov

Progesterone & Postpartum Relapse to Smoking

University of Minnesota·interventional·Posted Feb 25, 2013·Updated Jan 9, 2017

In Brief

A clinical study evaluating Progesterone and Placebo for Tobacco Use Cessation and Tobacco Use Disorder. Completed, enrolled 46 participants across 1 site.

Detailed Summary

The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Cessation, Tobacco Use Disorder
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2013
Enrollment StartJun 1, 2014
Primary CompletionJun 1, 2015
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.4 years ago

Interventions

Progesteronedrug

Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.

Placeboother

Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.