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Progesterone + Estradiol Modification for Smoking Relapse and Secondhand Smoke Exposure
This trial will test whether a progesterone-based contraceptive can help prevent postpartum smoking relapse and improve infant health.
- Smoking Cessation
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
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Who is running the clinical trial?
- You are currently using illegal drugs or abusing alcohol.You have received treatment for drug or alcohol addiction within the last three months.You cannot take progesterone treatment if you are currently taking certain medications that may interact with it, have a history of blood clots, bleeding disorders, high blood pressure, stroke, heart disease, liver dysfunction, or a peanut allergy.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.You are currently using any tobacco products like cigarettes or electronic cigarettes, or any medication or therapy to quit smoking.
- Group 1: Progesterone
- Group 2: Placebo
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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