CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 95 enrolled
Drug / intervention
Low-dose Progesterone +1 moredrug
Likely dose
High-dose Progesterone 200mgfrom 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/NCT01811225
NCT01811225Phase 2Completed
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Smoking, Sex Hormones, and Pregnancy

University of Minnesota·interventional·Posted Mar 14, 2013·Updated Nov 13, 2020

In Brief

A Phase 2 clinical trial evaluating Low-dose Progesterone and High-dose Progesterone for Nicotine Dependence and Contraception. Completed, enrolled 95 participants across 1 site.

Detailed Summary

The investigators aim to (1) examine the association between levels of progesterone (Prog), allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related symptomatology during ad libitum smoking and (2) determine the association between Prog, Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine following overnight abstinence

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNicotine Dependence, Contraception
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2013
Enrollment StartDec 1, 2012
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.3 years ago

Interventions

Low-dose Progesteronedrug

The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).

High-dose Progesteronedrug

The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).