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Progesterone + Estradiol Modification for Smoking Relapse and Secondhand Smoke Exposure

Phase 4
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
self-report of a minimum of 4 weeks of smoking abstinence with confirmation of acute abstinence by expired carbon monoxide level of ≤ 5 ppm at the time of enrollment
history of ≥ 5 cigarettes a day for at least 6 out of the last 12 months
Must not have
Be younger than 18 years old
Be older than 65 years old
Screening 3 weeks
Treatment Varies
Follow Up3months post-randomization
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Study Summary

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

Eligible Conditions
  • Smoking
  • Smoking Cessation

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have smoked at least 5 cigarettes a day for 6 months out of the last year.
You have stated that you are highly motivated to stay away from drugs or alcohol after giving birth, with a score of at least 7 out of 10 on a survey.
If you plan to have sex within 12 weeks after giving birth, you agree to use birth control methods that do not involve hormones.


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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effects of maternal smoking intervention on infant health
Efficacy of the intervention on smoking cessation postpartum
Efficacy of the intervention smoking relapse postpartum

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ProgesteroneActive Control1 Intervention
Participants in this group will receive progesterone plus the placebo injection treatment
Group II: PlaceboPlacebo Group1 Intervention
Participants in this group will receive the placebo oral pill and injection treatments

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,341 Previous Clinical Trials
1,582,125 Total Patients Enrolled
10 Trials studying Smoking
28,009 Patients Enrolled for Smoking
University of ArizonaOTHER
499 Previous Clinical Trials
147,243 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
1,925 Previous Clinical Trials
2,633,994 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: Progesterone, Placebo
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
~152 spots leftby Jun 2025