Trial Outcomes & Findings for Progesterone Augmentation of Nicotine Replacement Therapy Study (NCT NCT02685072)

NCT ID: NCT02685072

Last Updated: 2019-07-23

Results Overview

The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 64 participants
• Primary outcome timeframe: end of 8 weeks of treatment
• Results posted on: 2019-07-23

Participant Flow

Participant milestones

Measure	TNP + Progesterone Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Treatment Period STARTED	33	31
Treatment Period Completed Week 2 Visit	23	26
Treatment Period Completed Week 3 Visit	20	23
Treatment Period Completed Week 4 Visit	19	23
Treatment Period Completed Week 5 Visit	19	22
Treatment Period Completed Week 6 Visit	18	19
Treatment Period Completed Week 7 Visit	17	18
Treatment Period Completed Week 8 Visit	20	22
Treatment Period COMPLETED	20	22
Treatment Period NOT COMPLETED	13	9
1-Month Follow-Up STARTED	20	22
1-Month Follow-Up COMPLETED	19	22
1-Month Follow-Up NOT COMPLETED	1	0
3-Month Follow-Up STARTED	19	22
3-Month Follow-Up COMPLETED	19	22
3-Month Follow-Up NOT COMPLETED	0	0

Reasons for withdrawal

Measure	TNP + Progesterone Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Treatment Period Lost to Follow-up	12	6
Treatment Period Withdrawal by Subject	1	3
1-Month Follow-Up Withdrawal by Subject	1	0

Baseline Characteristics

Progesterone Augmentation of Nicotine Replacement Therapy Study

Baseline characteristics by cohort

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo	Total n=64 Participants Total of all reporting groups
Age, Continuous	32.3 years STANDARD_DEVIATION 7.6 • n=5 Participants	33.0 years STANDARD_DEVIATION 8.0 • n=7 Participants	32.6 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized MIxed Race	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cigarettes per day	11.4 cigarettes per day STANDARD_DEVIATION 7.0 • n=5 Participants	13.2 cigarettes per day STANDARD_DEVIATION 7.3 • n=7 Participants	12.3 cigarettes per day STANDARD_DEVIATION 7.2 • n=5 Participants
Motivation to quit smoking	9.0 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants	8.9 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	8.9 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants
Lives with smoker Lives with smoker	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Lives with smoker Does not live with smoker	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: end of 8 weeks of treatment

Population: Participants (n=13 in TPN + Progesterone; n=9 in TPN + Placebo) missing outcome data were coded as not abstinent.

The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.

Outcome measures

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
7-day Point Prevalence of Smoking Abstinence abstinent	8 Participants	11 Participants
7-day Point Prevalence of Smoking Abstinence not abstinent	25 Participants	20 Participants

SECONDARY outcome

Timeframe: end of 8 weeks of treatment

Population: Participants (n=13 in TPN + Progesterone; n=10 in TPN + Placebo) missing breath CO were coded as ≥ 10 ppm (positive for smoking).

Smoking abstinence measured by breath CO

Outcome measures

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Carbon Monoxide <10 Ppm CO <10 ppm	9 Participants	8 Participants
Carbon Monoxide <10 Ppm CO ≥ 10 ppm	24 Participants	23 Participants

SECONDARY outcome

Timeframe: 1 month follow up

Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).

Smoking abstinence measured by breath CO

Outcome measures

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Carbon Monoxide <10 Ppm CO <10 ppm	6 Participants	7 Participants
Carbon Monoxide <10 Ppm CO ≥ 10 ppm	27 Participants	24 Participants

SECONDARY outcome

Timeframe: 3 month follow up

Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).

Smoking abstinence measured by breath CO

Outcome measures

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Carbon Monoxide <10 Ppm CO <10 ppm	10 Participants	10 Participants
Carbon Monoxide <10 Ppm CO ≥ 10 ppm	23 Participants	21 Participants

SECONDARY outcome

Timeframe: baseline and week 2

Population: Includes people who completed Stroop Test at both baseline and Week 2 visits.

The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A Level 3 Stroop Throughput change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.

Outcome measures

Measure	TNP + Progesterone n=24 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=26 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Change in Stroop Measure of Inhibitory Function	4.1 units on a scale Standard Deviation 24.7	-5.0 units on a scale Standard Deviation 28.7

SECONDARY outcome

Timeframe: baseline and week 2

Population: Includes participants who completed the Go/No Go task at both baseline and week 2 visits.

Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the "3".

Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect responses. Higher scores represent a better outcome. For the change score, higher positive scores represent greater improvement in scores between baseline and week 2, and lower negative scores represent greater decline in scores between baseline and week 2.

Outcome measures

Measure	TNP + Progesterone n=24 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=26 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Change in Go/No Go Task Measure of Inhibitory Function	0.36 units on a scale Standard Deviation 2.33	0.50 units on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: baseline and week 2

Population: Includes participants who completed the Code Substitution-Learning Test.at both baseline and week 2 visits.

The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.

Outcome measures

Measure	TNP + Progesterone n=24 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=33 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Change in Digit Symbol Task Measure of Inhibitory Function	-3.95 units on a scale Standard Deviation 11.42	5.32 units on a scale Standard Deviation 11.59

SECONDARY outcome

Timeframe: Baseline

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	29.2 score on a scale Standard Deviation 7.0	25.6 score on a scale Standard Deviation 7.7
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	11.9 score on a scale Standard Deviation 2.1	11.4 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Week 2

Population: Note: numbered analyzed does not equal 24

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=23 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=26 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	27.0 score on a scale Standard Deviation 7.1	24.4 score on a scale Standard Deviation 8.3
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	11.4 score on a scale Standard Deviation 1.9	11.3 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Week 3

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=20 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=23 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	23.8 score on a scale Standard Deviation 8.6	27.0 score on a scale Standard Deviation 8.0
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	11.6 score on a scale Standard Deviation 2.1	12.1 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Week 4

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=19 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=23 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	28.0 score on a scale Standard Deviation 7.4	26.3 score on a scale Standard Deviation 9.1
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	10.6 score on a scale Standard Deviation 1.3	11.6 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Week 5

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=19 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=22 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	24.3 score on a scale Standard Deviation 8.6	27.9 score on a scale Standard Deviation 9.1
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	10.7 score on a scale Standard Deviation 1.0	10.6 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Week 6

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=18 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=19 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	25.9 score on a scale Standard Deviation 10.0	25.7 score on a scale Standard Deviation 10.0
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	10.9 score on a scale Standard Deviation 1.8	11.6 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Week 7

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=17 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=18 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	24.7 score on a scale Standard Deviation 9.1	24.7 score on a scale Standard Deviation 9.9
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	11.5 score on a scale Standard Deviation 3.2	10.9 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Week 8

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=20 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=21 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	25.2 score on a scale Standard Deviation 10.4	26.5 score on a scale Standard Deviation 10.3
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	11.6 score on a scale Standard Deviation 2.7	10.8 score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 1 month follow up

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=19 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=22 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	26.4 score on a scale Standard Deviation 8.7	26.4 score on a scale Standard Deviation 8.7
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	10.7 score on a scale Standard Deviation 1.1	11.0 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 3 month follow up

The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.

Outcome measures

Measure	TNP + Progesterone n=19 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=22 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Positive and Negative Affect Schedule (PANAS) Total Score Positive Affect Score	24.8 score on a scale Standard Deviation 7.8	27.7 score on a scale Standard Deviation 9.2
Positive and Negative Affect Schedule (PANAS) Total Score Negative Affect Score	11.3 score on a scale Standard Deviation 1.6	11.1 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 1-month follow-up after end of treatment

Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).

Abstinence from 2 weeks post quit date to the one month follow up

Outcome measures

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Prolonged Abstinence Post Trial abstinent	4 Participants	5 Participants
Prolonged Abstinence Post Trial not abstinent	29 Participants	26 Participants

SECONDARY outcome

Timeframe: 3-month follow-up after end of treatment

Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).

Abstinence from 2 weeks post quit date to 3 month follow up (total of 6-8 weeks during the trial and 3 month follow up)

Outcome measures

Measure	TNP + Progesterone n=33 Participants Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 Participants Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Prolonged Abstinence Follow up abstinent	4 Participants	5 Participants
Prolonged Abstinence Follow up not abstienent	29 Participants	26 Participants

Adverse Events

TNP + Progesterone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

TNP + Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TNP + Progesterone n=33 participants at risk Transdermal Nicotine Patch + Progesterone (200 mgs BID) Progesterone (200 mgs BID): TNP + Progesterone	TNP + Placebo n=31 participants at risk Transdermal Nicotine Patch + Placebo (for Progesterone) Placebo: TNP + Placebo
Gastrointestinal disorders nausea, vomiting, diarrhea	3.0% 1/33 • Number of events 1 • 3 months	0.00% 0/31 • 3 months
Musculoskeletal and connective tissue disorders wrist and back injury due to fall	3.0% 1/33 • Number of events 1 • 3 months	0.00% 0/31 • 3 months
Musculoskeletal and connective tissue disorders Back pain	3.0% 1/33 • Number of events 1 • 3 months	0.00% 0/31 • 3 months
Musculoskeletal and connective tissue disorders Muscle pain	3.0% 1/33 • Number of events 1 • 3 months	0.00% 0/31 • 3 months
General disorders ER visit for unknown reason	3.0% 1/33 • Number of events 1 • 3 months	6.5% 2/31 • Number of events 2 • 3 months
Reproductive system and breast disorders 3 Menses in one month	0.00% 0/33 • 3 months	3.2% 1/31 • Number of events 1 • 3 months
Reproductive system and breast disorders Ovarian cyst	0.00% 0/33 • 3 months	6.5% 2/31 • Number of events 2 • 3 months

Additional Information

Kimberly Yonkers, MD

Yale School of Public Health

Phone: (203) 764-6621

Email: kimberly.yonkers@yale.edu

Results disclosure agreements

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