Back to search results

Progesterone for Postpartum Smoking Relapse Prevention

This study is testing if a medication called Progesterone 200 MG Oral Capsule can help women who have recently given birth avoid smoking again (relapse) and reduce the amount of secondhand smoke their infants and children are exposed to. Researchers want to see if taking progesterone daily for 12 weeks can prevent women from smoking after childbirth. They will also look at how this affects the health of the baby. You might be able to join if you are a woman between 18 and 45 years old, have recently given birth or are in late pregnancy, have a history of smoking, and are motivated to quit or stay smoke-free. The study is currently unclear about its recruitment status.

Study design
This interventional study plans to enroll 171 women. It is not specified if participants will be randomly assigned to groups or if the study is blinded.
What's involved
Participants living in Minnesota will receive a 12-week course of progesterone. All participants will have remote visits, complete surveys, and provide self-collected dried blood samples.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six months after the study procedures.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04783857

Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

Recruiting
PHASE4Ages 18–45InterventionalPrevention
University of Minnesota
~171 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Progesterone 200 MG Oral Capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Smoking abstinence at Month 6
Measured over 6 months
+1 more outcome measured

Conditions

Smoking
Smoking Cessation
Smoking Reduction

Explore related trials

Smoking

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Sharon Allen, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Katherine Harrison, MPH
[email protected]
612-624-5377
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Ability to provide informed consent,
Aged 18 to 45 years old
Self-reported stable physical and mental health
History of ≥ 4 cigarettes per month during the six months prior to pregnancy
At enrollment, self-report of motivation to become and/or remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale
Willingness to protect against pregnancy following day 0 to week 12 of the study
Participants must live in the continental US and have a device to fully participate in the protocol

Exclusion

Current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
Current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory
Contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy),
Current or within the past 3 months treatment for illicit drug use or alcohol use
Any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.

What this trial measures

  • Smoking abstinence at Month 66 months
  • Child health assessed as smoke exposure and acute infant health.6 months