Trial Outcomes & Findings for Progesterone & Postpartum Relapse to Smoking (NCT NCT01798394)

NCT ID: NCT01798394

Last Updated: 2017-01-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: Week 4 Postpartum
• Results posted on: 2017-01-09

Participant Flow

Participant milestones

Measure	Progesterone Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Overall Study STARTED	24	22
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Progesterone & Postpartum Relapse to Smoking

Baseline characteristics by cohort

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.2 years STANDARD_DEVIATION 5.5 • n=5 Participants	26.7 years STANDARD_DEVIATION 5.0 • n=7 Participants	26.5 years STANDARD_DEVIATION 5.2 • n=5 Participants
Gender Female	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	22 participants n=7 Participants	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: 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	6 participants	7 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: 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 12 Postpartum	11 participants	13 participants

SECONDARY outcome

Timeframe: Postpartum Day 0 to 84

Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.

Outcome measures

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: 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 at All During Postpartum (up to Day 84)	10 participants	13 participants

SECONDARY outcome

Timeframe: Gestational Week 36 - Postpartum Week 12

Compliance was measured as the number of visits attended (maximum of 5).

Outcome measures

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Protocol Compliance - Number of Visits Attended	4.5 Number of visits attended Standard Deviation 1.1	4.4 Number of visits attended Standard Deviation 1.2

SECONDARY outcome

Timeframe: Postpartum Week 12

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.

Outcome measures

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Compliance Determinants	3.6 units on a scale Standard Deviation 0.3	3.5 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Postpartum Week 0 - Week 12

Compliance was measured by doses of medication taken (maximum of 56).

Outcome measures

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Protocol Compliance - Doses of Medication Taken	38.9 Doses of medication taken Standard Deviation 22.3	37.5 Doses of medication taken Standard Deviation 18.3

SECONDARY outcome

Timeframe: Gestational Week 36 - Postpartum Week 12

Compliance was measured as the number by number of EDCs completed (maximum of 84).

Outcome measures

Measure	Progesterone n=24 Participants Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 Participants Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Protocol Compliance - EDC's Completed	60.9 EDC's completed Standard Deviation 21.8	61.8 EDC's completed Standard Deviation 24.3

Adverse Events

Progesterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Progesterone n=24 participants at risk Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4. Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.	Placebo n=22 participants at risk Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4. Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
Surgical and medical procedures Hospitalization for post-cesarean section infection	0.00% 0/24 • 2 years	4.5% 1/22 • Number of events 1 • 2 years

Other adverse events

Adverse event data not reported

Additional Information

Nicole Tosun

University of Minnesota

Phone: 612-624-5439

Email: tosun004@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place