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Smoking, Sex Hormones, and Pregnancy

NCT01811225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2020-11-13

Study results available
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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

Conditions

  • Nicotine Dependence
  • Contraception

Interventions

DRUG

Low-dose Progesterone

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

DRUG

High-dose Progesterone

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

Sponsors & Collaborators

Principal Investigators

  • Sharon S. Allen, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2017-06-30
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01811225 on ClinicalTrials.gov