Trial Outcomes & Findings for Progesterone Effect on Individuals Diagnoses With AD and PTSD. (NCT NCT02187224)

NCT ID: NCT02187224

Last Updated: 2023-04-26

Results Overview

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 13 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-04-26

Participant Flow

Participant milestones

Measure	Progesterone All Study Participants For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant) Progesterone	Placebo All Study Participants For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant) Placebo (for Progesterone)
Overall Study STARTED	8	5
Overall Study Received Trauma Script First	1	4
Overall Study Received Neutral Script First	7	1
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Progesterone All Study Participants For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant) Progesterone	Placebo All Study Participants For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant) Placebo (for Progesterone)
Overall Study Did not show up for test day	1	0

Baseline Characteristics

Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Baseline characteristics by cohort

Measure	Progesterone All Study Participants n=8 Participants For the three days prior to each test day every participant in this arm will receive one progesterone capsule (200 mg. bid) on the first day and 2 progesterone capsules per day for days 2 and 3. On the test day the participant will receive the last progesterone capsule (200 mg.bid). On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant) Progesterone	Placebo All Study Participants n=5 Participants For the three days prior to each test day every participant in this arm will receive one placebo capsule on the first day and 2 placebo capsules per day for days 2 and 3. On the test day the participant will receive the last placebo capsule . On the test day two scripts will be read one trauma related script (most traumatic experience) and one neutral script (relaxed scene given by participant) Placebo (for Progesterone)	Total n=13 Participants Total of all reporting groups
Age, Continuous	48.4 years STANDARD_DEVIATION 8.1 • n=5 Participants	49.4 years STANDARD_DEVIATION 11.4 • n=7 Participants	48.9 years STANDARD_DEVIATION 9.75 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Craving (VASC) Baseline no Script	1.29 units on a scale Standard Error 0.78	0.60 units on a scale Standard Error 0.89	—	—

PRIMARY outcome

Timeframe: 10 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Craving (VASC) 10 Minutes (Pre-script #1)	0.16 units on a scale Standard Error 1.73	0 units on a scale Standard Error 0.97	0.81 units on a scale Standard Error 0.80	0.32 units on a scale Standard Error 1.75

PRIMARY outcome

Timeframe: 25 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Craving (VASC) 25 Minutes (Post-Script #1)	2.14 units on a scale Standard Error 1.80	3.93 units on a scale Standard Error 0.97	1.14 units on a scale Standard Error 0.80	0.33 units on a scale Standard Error 1.74

PRIMARY outcome

Timeframe: 40 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Craving (VASC) 40 Minutes (Post-Recovery #1)	1.15 units on a scale Standard Error 1.75	1.92 units on a scale Standard Error 0.97	1.30 units on a scale Standard Error 0.79	0.40 units on a scale Standard Error 1.60

PRIMARY outcome

Timeframe: 65 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Craving (VASC) 65 Minutes (Pre-Script #2)	0.82 units on a scale Standard Error 0.81	0.20 units on a scale Standard Error 1.90	3.19 units on a scale Standard Error 1.60	0 units on a scale Standard Error 0.95

PRIMARY outcome

Timeframe: 80 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Craving (VASC) 80 Minutes (Post-Script #2)	3.15 units on a scale Standard Error 0.80	2.27 units on a scale Standard Error 1.83	1.13 units on a scale Standard Error 1.81	0 units on a scale Standard Error 0.98

PRIMARY outcome

Timeframe: 95 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Craving (VASC) 95 Minutes (Post-Recovery #2)	1.81 units on a scale Standard Error 0.80	4.31 units on a scale Standard Error 1.76	2.14 units on a scale Standard Error 1.79	0 units on a scale Standard Error 0.97

PRIMARY outcome

Timeframe: Baseline

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Anxiety (VASA) Baseline no Script	0.64 units on a scale Standard Error 0.79	3.20 units on a scale Standard Error 0.89	—	—

PRIMARY outcome

Timeframe: 10 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Anxiety (VASA) 10 Minutes (Pre-Script #1)	0 units on a scale Standard Error 1.68	1.26 units on a scale Standard Error 0.96	0.20 units on a scale Standard Error 0.80	0 units on a scale Standard Error 1.78

PRIMARY outcome

Timeframe: 25 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Anxiety (VASA) 25 Minutes (Post-Script #1)	2.82 units on a scale Standard Error 1.76	7.98 units on a scale Standard Error 0.97	0.03 units on a scale Standard Error 0.80	0 units on a scale Standard Error 1.79

PRIMARY outcome

Timeframe: 40 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Anxiety (VASA) 40 Minutes (Post-Recovery #1)	0 units on a scale Standard Error 1.91	4.39 units on a scale Standard Error 0.99	0.85 units on a scale Standard Error 0.81	0 units on a scale Standard Error 1.95

PRIMARY outcome

Timeframe: 65 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Anxiety (VASA) 65 Minutes (Pre-Script #2)	0.18 units on a scale Standard Error 0.81	0 units on a scale Standard Error 1.94	0 units on a scale Standard Error 1.90	2.15 units on a scale Standard Error 0.98

PRIMARY outcome

Timeframe: 80 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Anxiety (VASA) 80 Minutes (Post-Script #2)	3.67 units on a scale Standard Error 0.81	9.89 units on a scale Standard Error 1.99	0 units on a scale Standard Error 1.90	1.90 units on a scale Standard Error 0.98

PRIMARY outcome

Timeframe: 95 minutes

Population: All available data was utilized in the analysis using mixed models

Visual Analogue Scale of Anxiety (VASA) is a self-report rating scale using the Likert scale (0 Not at all Anxious - 10 Extremely Anxious)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Visual Analogue Scale of Anxiety (VASA) 95 Minutes (Post-Recovery #2)	1.68 units on a scale Standard Error 0.81	9.76 units on a scale Standard Error 1.98	0 units on a scale Standard Error 1.98	2.05 units on a scale Standard Error 0.99

SECONDARY outcome

Timeframe: Baseline

Population: All available data was utilized in the analysis using mixed models

Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
State Trait Anxiety Inventory (STAI-6) Baseline no Script	7.86 units on a scale Standard Error 0.911	9.60 units on a scale Standard Error 1.08	—	—

SECONDARY outcome

Timeframe: 10 minutes

Population: All available data was utilized in the analysis using mixed models

Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Six-item State-Trait Anxiety Inventory (STAI-6) 10 Minutes (Pre-Script #1)	6.00 units on a scale Standard Error 2.65	7.50 units on a scale Standard Error 1.32	6.50 units on a scale Standard Error 0.96	5.00 units on a scale Standard Error 2.35

SECONDARY outcome

Timeframe: 25 minutes

Population: All available data was utilized in the analysis using mixed models

Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Six-item State-Trait Anxiety Inventory (STAI-6) 25 Minutes (Post-Script #1)	11.00 units on a scale Standard Error 2.75	16.25 units on a scale Standard Error 1.38	6.17 units on a scale Standard Error 0.60	5.00 units on a scale Standard Error 1.47

SECONDARY outcome

Timeframe: 40 minutes

Population: All available data was utilized in the analysis using mixed models

Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Six-item State-Trait Anxiety Inventory (STAI-6) 40 Minutes (Post-Recovery #1)	9.00 units on a scale Standard Error 0.82	14.00 units on a scale Standard Error 0.41	7.07 units on a scale Standard Error 0.87	8.00 units on a scale Standard Error 2.14

SECONDARY outcome

Timeframe: 65 minutes

Population: All available data was utilized in the analysis using mixed models

Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Six-item State-Trait Anxiety Inventory (STAI-6) 65 Minutes (Pre-Script #2)	6.50 units on a scale Standard Error 0.67	5.00 units on a scale Standard Error 1.64	9.00 units on a scale Standard Error 3.16	9.00 units on a scale Standard Error 1.58

SECONDARY outcome

Timeframe: 80 minutes

Population: All available data was utilized in the analysis using mixed models

Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Six-item State-Trait Anxiety Inventory (STAI-6) 80 Minutes (Post-Script #2)	14.17 units on a scale Standard Error 2.27	18.00 units on a scale Standard Error 5.57	6.00 units on a scale Standard Error 4.36	8.50 units on a scale Standard Error 2.18

SECONDARY outcome

Timeframe: 95 minutes

Population: All available data was utilized in the analysis using mixed models

Six-item State-Trait Anxiety Inventory (STAI-6) is a psychological inventory consisting of 6 self-report items on a 4-point Likert scale. The STAI-6 measures state anxiety. Higher scores are positively correlated with higher levels of anxiety. STAI-6 scores are classified as "no or low anxiety" (6-12), "moderate anxiety" (13-18), and "high anxiety" (19-24). (minimum score of 6 to a maximum score of 24)

Outcome measures

Measure	Progesterone n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)	Progesterone Neutral Script n=7 Participants For the three days prior to each test day every participant in this arm will receive progesterone. Progesterone	Placebo Neutral Script n=5 Participants For the three days prior to each test day every participant in this arm will receive placebo. Placebo (for Progesterone)
Six-item State-Trait Anxiety Inventory (STAI-6) (STAI-6) 95 Minutes (Post-Recovery #2)	11.17 units on a scale Standard Error 1.96	14.00 units on a scale Standard Error 4.79	8.00 units on a scale Standard Error 3.95	8.25 units on a scale Standard Error 1.97

Adverse Events

Progesterone All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Ralevski

Yale University School of Medicine, Department of Psychiatry

Phone: 203-932-5711

Email: elizabeth.ralevski@yale.edu

Results disclosure agreements

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