Trial Outcomes & Findings for Progesterone for Smoking Relapse Prevention Following Delivery (NCT NCT01972464)
NCT ID: NCT01972464
Last Updated: 2018-01-17
Results Overview
Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
8 weeks
Results posted on
2018-01-17
Participant Flow
Recruitment began January 2014 and final data collection occurred August 2016. We accepted study referrals and conducted on-site clinic screening assessments in three academic obstetrics clinics associated with Yale New Haven Hospital.
We screened 90 pregnant women who were current smokers intending to quit prior to 32 weeks gestation; 26 were ineligible because they were still smoking at 32 weeks gestation (n=12) or did not meet other eligibility criteria (n=14); 23 were eligible but not randomized because they declined to participate (n=8) or were out of contact (n=15).
Participant milestones
| Measure |
Placebo
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
Treatment Period (Week 1 Through Week 8)
STARTED
|
19
|
22
|
|
Treatment Period (Week 1 Through Week 8)
COMPLETED
|
16
|
18
|
|
Treatment Period (Week 1 Through Week 8)
NOT COMPLETED
|
3
|
4
|
|
3-Month Follow-Up (Week 20)
STARTED
|
16
|
18
|
|
3-Month Follow-Up (Week 20)
COMPLETED
|
15
|
17
|
|
3-Month Follow-Up (Week 20)
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
Treatment Period (Week 1 Through Week 8)
Lost to Follow-up
|
2
|
3
|
|
Treatment Period (Week 1 Through Week 8)
Patient Relocated
|
1
|
0
|
|
Treatment Period (Week 1 Through Week 8)
Withdrawal by Subject
|
0
|
1
|
|
3-Month Follow-Up (Week 20)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
4 participants did not report this information
Baseline characteristics by cohort
| Measure |
Placebo
n=19 Participants
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
n=22 Participants
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 4.3 • n=19 Participants
|
26.2 years
STANDARD_DEVIATION 4.9 • n=22 Participants
|
25.8 years
STANDARD_DEVIATION 4.6 • n=41 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=19 Participants
|
22 Participants
n=22 Participants
|
41 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=19 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black, non-Latina
|
13 Participants
n=19 Participants
|
9 Participants
n=22 Participants
|
22 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latina
|
4 Participants
n=19 Participants
|
11 Participants
n=22 Participants
|
15 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, non-Latina
|
1 Participants
n=19 Participants
|
2 Participants
n=22 Participants
|
3 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · More than one race, non-Latina
|
1 Participants
n=19 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=41 Participants
|
|
Education level
<High school degree
|
3 Participants
n=19 Participants
|
6 Participants
n=22 Participants
|
9 Participants
n=41 Participants
|
|
Education level
High school degree
|
9 Participants
n=19 Participants
|
13 Participants
n=22 Participants
|
22 Participants
n=41 Participants
|
|
Education level
Some college (no degree)
|
7 Participants
n=19 Participants
|
3 Participants
n=22 Participants
|
10 Participants
n=41 Participants
|
|
Lives with spouse or partner
Yes
|
10 Participants
n=19 Participants
|
10 Participants
n=22 Participants
|
20 Participants
n=41 Participants
|
|
Lives with spouse or partner
No
|
9 Participants
n=19 Participants
|
12 Participants
n=22 Participants
|
21 Participants
n=41 Participants
|
|
Lives with smoker
Yes
|
8 Participants
n=16 Participants • 4 participants did not report this information
|
10 Participants
n=21 Participants • 4 participants did not report this information
|
18 Participants
n=37 Participants • 4 participants did not report this information
|
|
Lives with smoker
No
|
8 Participants
n=16 Participants • 4 participants did not report this information
|
11 Participants
n=21 Participants • 4 participants did not report this information
|
19 Participants
n=37 Participants • 4 participants did not report this information
|
|
Parity
1
|
3 Participants
n=19 Participants
|
8 Participants
n=22 Participants
|
11 Participants
n=41 Participants
|
|
Parity
2
|
8 Participants
n=19 Participants
|
4 Participants
n=22 Participants
|
12 Participants
n=41 Participants
|
|
Parity
3
|
4 Participants
n=19 Participants
|
7 Participants
n=22 Participants
|
11 Participants
n=41 Participants
|
|
Parity
4+
|
4 Participants
n=19 Participants
|
3 Participants
n=22 Participants
|
7 Participants
n=41 Participants
|
|
Pre-quit number of cigarettes per day
|
7.1 participants
STANDARD_DEVIATION 3.3 • n=16 Participants • 6 participants did not report this information
|
6.2 participants
STANDARD_DEVIATION 4.3 • n=19 Participants • 6 participants did not report this information
|
6.6 participants
STANDARD_DEVIATION 3.9 • n=35 Participants • 6 participants did not report this information
|
|
Pre-quit smoking level
≤10 cigarettes/day
|
17 Participants
n=19 Participants
|
17 Participants
n=22 Participants
|
34 Participants
n=41 Participants
|
|
Pre-quit smoking level
10 cigarettes/day
|
2 Participants
n=19 Participants
|
5 Participants
n=22 Participants
|
7 Participants
n=41 Participants
|
|
Breastfeeding intentions
Breastfeed exclusively
|
4 Participants
n=19 Participants
|
9 Participants
n=22 Participants
|
13 Participants
n=41 Participants
|
|
Breastfeeding intentions
Breasefeed and formula feed
|
10 Participants
n=19 Participants
|
11 Participants
n=22 Participants
|
21 Participants
n=41 Participants
|
|
Breastfeeding intentions
Formula feed exclusively
|
4 Participants
n=19 Participants
|
2 Participants
n=22 Participants
|
6 Participants
n=41 Participants
|
|
Breastfeeding intentions
Unsure
|
1 Participants
n=19 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=41 Participants
|
|
Feeding method at week 2 visit
Breastfeed exclusively
|
0 Participants
n=19 Participants
|
6 Participants
n=22 Participants
|
6 Participants
n=41 Participants
|
|
Feeding method at week 2 visit
Breasefeed and formula feed
|
3 Participants
n=19 Participants
|
5 Participants
n=22 Participants
|
8 Participants
n=41 Participants
|
|
Feeding method at week 2 visit
Formula feed exclusively
|
14 Participants
n=19 Participants
|
7 Participants
n=22 Participants
|
21 Participants
n=41 Participants
|
|
Feeding method at week 2 visit
Missing
|
2 Participants
n=19 Participants
|
4 Participants
n=22 Participants
|
6 Participants
n=41 Participants
|
|
Fagerstrom Test for Nicotine Dependence
Low dependence
|
6 Participants
n=19 Participants
|
7 Participants
n=22 Participants
|
13 Participants
n=41 Participants
|
|
Fagerstrom Test for Nicotine Dependence
Low to moderate dependence
|
9 Participants
n=19 Participants
|
11 Participants
n=22 Participants
|
20 Participants
n=41 Participants
|
|
Fagerstrom Test for Nicotine Dependence
Moderate dependence
|
4 Participants
n=19 Participants
|
4 Participants
n=22 Participants
|
8 Participants
n=41 Participants
|
|
Fagerstrom Test for Nicotine Dependence
High dependence
|
0 Participants
n=19 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=41 Participants
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
|
15.6 units on a scale
STANDARD_DEVIATION 15.4 • n=19 Participants
|
18.0 units on a scale
STANDARD_DEVIATION 12.2 • n=22 Participants
|
16.9 units on a scale
STANDARD_DEVIATION 13.7 • n=41 Participants
|
|
Edinburgh Postnatal Depression Scale Score
|
3.8 units on a scale
STANDARD_DEVIATION 4.9 • n=19 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 4.5 • n=22 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 4.7 • n=41 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Adherence to treatment as measured by mean (SD) doses of study medication taken by women in each arm of the study.
Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken
Outcome measures
| Measure |
Placebo
n=19 Participants
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
n=22 Participants
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment
|
84.5 doses of medication
Standard Deviation 38.3
|
76.0 doses of medication
Standard Deviation 42.0
|
PRIMARY outcome
Timeframe: From randomization to 3-month follow-up: up to 5 monthsFeasibility in retention will be shown by at least 70% of women randomized to the progesterone group reamaining in the study at the 3-month follow-up
Outcome measures
| Measure |
Placebo
n=19 Participants
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
n=22 Participants
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Week 8 of the trial periodAbstinence was defined as self-report of no smoking in the past 7 days confirmed by a negative urine cotinine test (urine cotinine \<100 ng/ml).
Outcome measures
| Measure |
Placebo
n=19 Participants
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
n=22 Participants
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
7-day Point Prevalence of Abstinence at End of Treatment (Week 8)
|
6 Participants
|
10 Participants
|
POST_HOC outcome
Timeframe: baseline through 3-month post trial follow-upThe Outcome Measure is reporting the time in weeks to relapse
Outcome measures
| Measure |
Placebo
n=19 Participants
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
n=22 Participants
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
Time to Relapse
|
4 weeks
Interval 2.0 to 10.0
|
10 weeks
Interval 3.0 to
For the Inter-Quartile Range in the progesterone group, \> than 25% of the data were right censored so 75th percentile could not be calculated
|
POST_HOC outcome
Timeframe: treatment period; baseline through week 8, measured weeklyScale is scored from 10 to 70. Higher scores indicate more severe symptoms
Outcome measures
| Measure |
Placebo
n=19 Participants
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
n=22 Participants
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
baseline
|
15.6 units on a scale
Standard Deviation 15.4
|
18.0 units on a scale
Standard Deviation 12.2
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
week 1
|
13.3 units on a scale
Standard Deviation 5.6
|
14.5 units on a scale
Standard Deviation 10.5
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
weeek 2
|
14.1 units on a scale
Standard Deviation 7.8
|
13.7 units on a scale
Standard Deviation 7.5
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
week 3
|
15.5 units on a scale
Standard Deviation 9.7
|
14.5 units on a scale
Standard Deviation 9.1
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
week 4
|
18.3 units on a scale
Standard Deviation 10.6
|
12.2 units on a scale
Standard Deviation 3.8
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
week 5
|
15.7 units on a scale
Standard Deviation 6.8
|
13.8 units on a scale
Standard Deviation 8.5
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
week 6
|
17.9 units on a scale
Standard Deviation 10.0
|
12.1 units on a scale
Standard Deviation 5.1
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
week 7
|
17.2 units on a scale
Standard Deviation 8.6
|
10.6 units on a scale
Standard Deviation 2.4
|
|
Questionnaire on Smoking Urges (QSU)-Brief Score
week 8
|
21.4 units on a scale
Standard Deviation 17.5
|
10.4 units on a scale
Standard Deviation 1.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Progesterone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=19 participants at risk
In this group women will receive a placebo pill which will appear similar to progesterone and will be inert.
Placebo
|
Progesterone
n=22 participants at risk
In this group women will receive oral micronized progesterone twice a day.
Progesterone
|
|---|---|---|
|
General disorders
headache
|
5.3%
1/19 • Number of events 1 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
0.00%
0/22 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
|
General disorders
feeling Warm
|
5.3%
1/19 • Number of events 2 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
0.00%
0/22 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
|
General disorders
Itching
|
5.3%
1/19 • Number of events 1 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
0.00%
0/22 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
|
Reproductive system and breast disorders
abnormal pap smear
|
0.00%
0/19 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
4.5%
1/22 • Number of events 1 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
|
Reproductive system and breast disorders
heavy menses
|
0.00%
0/19 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
4.5%
1/22 • Number of events 1 • baseline through teh 8 week trial period and the 3-month follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place