Trial Outcomes & Findings for Sex Differences, Hormones & Smoking Cessation (NCT NCT01744574)
NCT ID: NCT01744574
Last Updated: 2019-07-12
Results Overview
7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
Week 4
Results posted on
2019-07-12
Participant Flow
Participant milestones
| Measure |
Placebo-Males
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Females
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
56
|
52
|
51
|
|
Overall Study
COMPLETED
|
33
|
31
|
32
|
40
|
|
Overall Study
NOT COMPLETED
|
24
|
25
|
20
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex Differences, Hormones & Smoking Cessation
Baseline characteristics by cohort
| Measure |
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
37.9 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
36.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
37.1 years
STANDARD_DEVIATION 9.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race (non-white)
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race (white)
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
128 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 47-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4
Outcome measures
| Measure |
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4
|
9 Participants
|
18 Participants
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Weeks 8 and 127-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to weeks 8 and 12
Outcome measures
| Measure |
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12
Week 8
|
10 Participants
|
16 Participants
|
10 Participants
|
10 Participants
|
|
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12
Week 12
|
12 Participants
|
20 Participants
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12Prolonged abstinence defined as having less than seven consecutive slips without a 24-hour period between any two slips prior to weeks 4, 8 and 12
Outcome measures
| Measure |
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12
Week 4
|
10 Participants
|
18 Participants
|
15 Participants
|
11 Participants
|
|
Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12
Week 8
|
8 Participants
|
15 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12
Week 12
|
7 Participants
|
13 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 12continuous abstinence defined as having no slips at all prior to week 12
Outcome measures
| Measure |
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Number of Participants With Continuous Abstinence From Smoking at Week 12
|
2 Participants
|
8 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12urine cotinine \<50 ng/mL at weeks 4, 8 and 12
Outcome measures
| Measure |
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12
Week 4
|
8 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12
Week 8
|
8 Participants
|
10 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12
Week 12
|
9 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8 and 12breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12
Outcome measures
| Measure |
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12
Week 4
|
18 Participants
|
22 Participants
|
17 Participants
|
20 Participants
|
|
Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12
Week 8
|
16 Participants
|
17 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12
Week 12
|
20 Participants
|
19 Participants
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 84Days to relapse defined as the number of days from quit date to the first day with a slip
Outcome measures
| Measure |
Placebo-Females
n=52 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Males
n=57 Participants
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 Participants
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Average Number of Days to Relapse
|
14.3 days
Standard Deviation 26.8
|
20.5 days
Standard Deviation 29.6
|
13.3 days
Standard Deviation 23.8
|
13.4 days
Standard Deviation 25.9
|
Adverse Events
Placebo-Males
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Progesterone-Males
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo-Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Progesterone-Females
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Males
n=57 participants at risk
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Males
n=56 participants at risk
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Placebo-Females
n=52 participants at risk
Placebo - subjects will take one placebo capsule twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
Progesterone-Females
n=51 participants at risk
Progesterone - The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). Subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
|
|---|---|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/57 • Adverse events were collected between enrollment and study completion (or study dropout) which ever came first; an average of 16 weeks .
|
1.8%
1/56 • Number of events 1 • Adverse events were collected between enrollment and study completion (or study dropout) which ever came first; an average of 16 weeks .
|
0.00%
0/52 • Adverse events were collected between enrollment and study completion (or study dropout) which ever came first; an average of 16 weeks .
|
0.00%
0/51 • Adverse events were collected between enrollment and study completion (or study dropout) which ever came first; an average of 16 weeks .
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place