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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
Must not have
contraindications to DMPA treatment (e.g., current use of aminoglutethimide or planning to become pregnant in the next year)
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

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.
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.
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
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I have smoked at least 5 cigarettes daily for 6 months in the past year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not using aminoglutethimide or planning to get pregnant soon.
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I cannot take progesterone due to a health condition or medication I am on.
Select...
I am currently using tobacco products or nicotine replacement therapy.
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I have been diagnosed with major depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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
1,434 Previous Clinical Trials
1,621,423 Total Patients Enrolled
11 Trials studying Smoking
28,069 Patients Enrolled for Smoking
University of ArizonaOTHER
536 Previous Clinical Trials
159,661 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
2,055 Previous Clinical Trials
2,731,607 Total Patients Enrolled
4 Trials studying Smoking
4,508 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
~45 spots leftby Jun 2025
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