An interventional study of Progesterone and Placebo in Tobacco Use Cessation and Tobacco Use Disorder, sponsored by University of Minnesota. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-09.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.
Pregnant women will be recruited at gestational weeks 33-36 who have quit smoking during pregnancy and are motivated to maintain abstinence after delivery. At the time of delivery, women will be randomly assigned to receive 4 weeks of active or placebo exogenous progesterone starting on the 4th day postpartum. Participants will be in contact with study staff either by phone or clinic visits until 12 weeks postpartum to collect data on smoking status and protocol compliance, measure serum progesterone levels and receive behavioral counseling.
968 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's enrollment of 46 is below the median of 90 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Drug: Progesterone
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Other: Placebo
Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
Also known as: Prometrium
Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Number of Participants Who Relapsed by Week 4 Postpartum
Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.
Time frame: Week 4 Postpartum
Number of Participants Who Relapsed by Week 12 Postpartum
Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.
Time frame: Week 12 Postpartum
Number of Participants Who Relapsed at All During Postpartum (up to Day 84)
Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.
Time frame: Postpartum Day 0 to 84
Protocol Compliance - Number of Visits Attended
Compliance was measured as the number of visits attended (maximum of 5).
Time frame: Gestational Week 36 - Postpartum Week 12
Compliance Determinants
This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.
Time frame: Postpartum Week 12
Protocol Compliance - Doses of Medication Taken
Compliance was measured by doses of medication taken (maximum of 56).
Time frame: Postpartum Week 0 - Week 12
Protocol Compliance - EDC's Completed
Compliance was measured as the number by number of EDCs completed (maximum of 84).
Time frame: Gestational Week 36 - Postpartum Week 12
| Milestone | Progesterone | Placebo |
|---|---|---|
| Started | 24 | 22 |
| Completed | 21 | 19 |
| Not completed | 3 | 3 |
Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.
| participants | Progesterone | Placebo |
|---|---|---|
| Number of Participants Who Relapsed by Week 4 Postpartum | 6 | 7 |
Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.
| participants | Progesterone | Placebo |
|---|---|---|
| Number of Participants Who Relapsed by Week 12 Postpartum | 11 | 13 |
Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.
| participants | Progesterone | Placebo |
|---|---|---|
| Number of Participants Who Relapsed at All During Postpartum (up to Day 84) | 10 | 13 |
Compliance was measured as the number of visits attended (maximum of 5).
| Number of visits attended | Progesterone | Placebo |
|---|---|---|
| Protocol Compliance - Number of Visits Attended | 4.5 ± 1.1 | 4.4 ± 1.2 |
This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.
| units on a scale | Progesterone | Placebo |
|---|---|---|
| Compliance Determinants | 3.6 ± 0.3 | 3.5 ± 0.3 |
Compliance was measured by doses of medication taken (maximum of 56).
| Doses of medication taken | Progesterone | Placebo |
|---|---|---|
| Protocol Compliance - Doses of Medication Taken | 38.9 ± 22.3 | 37.5 ± 18.3 |
Compliance was measured as the number by number of EDCs completed (maximum of 84).
| EDC's completed | Progesterone | Placebo |
|---|---|---|
| Protocol Compliance - EDC's Completed | 60.9 ± 21.8 | 61.8 ± 24.3 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Progesterone | — | 0/24 (0%) | 0/24 (0%) |
| Placebo | — | 1/22 (4.5%) | 0/22 (0%) |
| Event | Progesterone | Placebo |
|---|---|---|
| Hospitalization for post-cesarean section infectionSurgical and medical procedures | 0/24 | 1/22 |
| Age, Categorical(Participants) | Progesterone | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 22 | 46 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Progesterone | Placebo | Total |
|---|---|---|---|
| Mean | 26.2 ± 5.5 | 26.7 ± 5.0 | 26.5 ± 5.2 |
| Gender(Participants) | Progesterone | Placebo | Total |
|---|---|---|---|
| Female | 24 | 22 | 46 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Progesterone | Placebo | Total |
|---|---|---|---|
| United States | 24 | 22 | 46 |
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