← Back to Search

Progestin

Progesterone for Postpartum Smoking Relapse

Phase 4
Recruiting
Led By Sharon Allen, MD, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
history of ≥ 5 cigarettes a day for at least 6 out of the last 12 months
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will test whether a progesterone-based contraceptive can help prevent postpartum smoking relapse and improve infant health.

Who is the study for?
This trial is for women in stable health who are 30-35 weeks pregnant, have quit smoking for at least 4 weeks, and are motivated to stay smoke-free postpartum. They must not be planning pregnancy soon after delivery, using illicit drugs or alcohol excessively, or have certain medical conditions like heart disease or a history of blood clots.Check my eligibility
What is being tested?
The study tests if Progesterone (a hormone capsule) can help new moms avoid starting smoking again after giving birth compared to a placebo (a dummy pill). It also looks at how this might benefit the baby's health and explores if there are differences in outcomes based on race and ethnicity.See study design
What are the potential side effects?
Progesterone may cause side effects such as headaches, breast tenderness, bloating, mood swings, allergic reactions in those with peanut allergies since the medication contains peanut oil. The placebo is unlikely to cause any direct side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have smoked at least 5 cigarettes daily for 6 months in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child health assessed as smoke exposure and acute infant health.
Smoking abstinence at Month 6

Trial Design

2Treatment groups
Active Control
Group I: Group 2Active Control1 Intervention
Participants in this group will not receive progesterone
Group II: Group 1Active Control1 Intervention
Participants in this group will receive progesterone

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,466 Total Patients Enrolled
10 Trials studying Smoking
28,009 Patients Enrolled for Smoking
University of ArizonaOTHER
514 Previous Clinical Trials
148,315 Total Patients Enrolled
1 Trials studying Smoking
1,200 Patients Enrolled for Smoking
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,518 Total Patients Enrolled
3 Trials studying Smoking
1,508 Patients Enrolled for Smoking

Media Library

Depot-Medroxyprogestereone Acetate (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT04783857 — Phase 4
Smoking Research Study Groups: Group 2, Group 1
Smoking Clinical Trial 2023: Depot-Medroxyprogestereone Acetate Highlights & Side Effects. Trial Name: NCT04783857 — Phase 4
Depot-Medroxyprogestereone Acetate (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04783857 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program accept participants aged 35 and above?

"The requirements of this trial are narrow, and only those aged 18 to 40 can be considered. There exist 178 trials for minors under the age of 18 and 1090 for seniors over 65 years old."

Answered by AI

How many participants are partaking in the experiment?

"Indeed, clinicaltrials.gov has recorded that this investigation is currently open for patients to join. It was posted on April 14th 2022 and last modified June 30th 2022 with the aim of recruiting 312 participants from two medical sites."

Answered by AI

Are there any opportunities for people to enroll in this clinical trial?

"Affirmative. Details published on clinicaltrials.gov demonstrate that this medical study, which initially posted in April 14th 2022 is currently recruiting participants. A total of 312 subjects are required from two separate sites."

Answered by AI

What medical purposes is Depot-Medroxyprogestereone Acetate commonly employed for?

"Depot-Medroxyprogestereone Acetate is primarily utilized for the abatement of uterine hemorrhaging. It can additionally be prescribed to diagnose and treat hormone imbalances, avert recurrent spontaneous preterm birth, or address endometrial hyperplasia instigated by conjugated estrogen."

Answered by AI

Is the application of Depot-Medroxyprogestereone Acetate safe for humans?

"There is a great deal of data attesting to the safety of Depot-Medroxyprogestereone Acetate, so it received a high rating of 3."

Answered by AI

For what type of patient is enrollment in this experiment appropriate?

"The parameters to be included in this medical research are smoking reduction and being between 18-40 years old. Around 312 patients will be accepted into the trial."

Answered by AI

Is there precedent for successful therapeutic experimentation with Depot-Medroxyprogestereone Acetate?

"Depot-Medroxyprogestereone Acetate was first studied at the National Institutes of Health Clinical Center in 1996, and thus far there have been 372 clinical trials completed. Currently, 42 active studies related to this medication are being conducted around the world; most notably a large portion is taking place near Tucson, Arizona."

Answered by AI

Who else is applying?

What site did they apply to?
University of Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
2022. "Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04783857.
~98 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top