Trial Outcomes & Findings for Progesterone for Postpartum Cocaine Relapse (NCT NCT01249274)
NCT ID: NCT01249274
Last Updated: 2017-03-28
Results Overview
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Weekly measurements, Baseline to 12 weeks
Results posted on
2017-03-28
Participant Flow
On-site clinic screening assessments were performed in three obstetrics clinic associated with the Yale New Haven Hospital System in New Haven, CT, USA. Study referrals were accepted from the New Haven area. Both post-partum and pregnant women were screened. Screenings began in October of 2010 and finished in February of 2013.
75 women were scheduled for intake, but 24 did not complete intake interview and 1 was ineligible for randomisation because of a medical issue. The first 50 eligible women were randomly assigned.
Participant milestones
| Measure |
Placebo
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
Completed Treatment
|
21
|
19
|
|
Overall Study
Completed Treatment & Post Trial Visit
|
20
|
17
|
|
Overall Study
Completed Post Trial Visit But Not tx
|
1
|
2
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Received inpatient substance treatment
|
1
|
2
|
Baseline Characteristics
Progesterone for Postpartum Cocaine Relapse
Baseline characteristics by cohort
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 6.3 • n=93 Participants
|
30.5 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
31.6 years
STANDARD_DEVIATION 2.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=93 Participants
|
16 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
12 participants
n=93 Participants
|
4 participants
n=4 Participants
|
16 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or other
|
1 participants
n=93 Participants
|
5 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=93 Participants
|
25 participants
n=4 Participants
|
50 participants
n=27 Participants
|
|
Education
Less than high shool
|
9 participants
n=93 Participants
|
4 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Education
High school
|
8 participants
n=93 Participants
|
9 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Education
Post-high school
|
8 participants
n=93 Participants
|
12 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Marital status
Married or cohabitating
|
5 participants
n=93 Participants
|
7 participants
n=4 Participants
|
12 participants
n=27 Participants
|
|
Marital status
Divorced
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Marital status
Separated
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Marital status
Dating
|
6 participants
n=93 Participants
|
1 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Marital status
Single
|
9 participants
n=93 Participants
|
14 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Employment status
In paid employment
|
7 participants
n=93 Participants
|
3 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Employment status
Not in paid employment
|
17 participants
n=93 Participants
|
20 participants
n=4 Participants
|
37 participants
n=27 Participants
|
|
Employment status
Unknown
|
1 participants
n=93 Participants
|
2 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Weeks post partum
|
3.4 weeks
STANDARD_DEVIATION 5.1 • n=93 Participants
|
3.6 weeks
STANDARD_DEVIATION 4.6 • n=4 Participants
|
3.5 weeks
STANDARD_DEVIATION 2.3 • n=27 Participants
|
|
Lifetime cocaine use (years)
|
8.5 years
STANDARD_DEVIATION 7.2 • n=93 Participants
|
6.2 years
STANDARD_DEVIATION 4.2 • n=4 Participants
|
7.4 years
STANDARD_DEVIATION 2.8 • n=27 Participants
|
|
Age at first cocaine use (years)
|
20.6 years
STANDARD_DEVIATION 6.3 • n=93 Participants
|
19.2 years
STANDARD_DEVIATION 4.0 • n=4 Participants
|
19.9 years
STANDARD_DEVIATION 2.2 • n=27 Participants
|
|
Parity
|
2.6 births
STANDARD_DEVIATION 1.6 • n=93 Participants
|
2.1 births
STANDARD_DEVIATION 1.4 • n=4 Participants
|
2.4 births
STANDARD_DEVIATION 0.2 • n=27 Participants
|
|
EPDS score at intake
|
11.2 units on a scale
STANDARD_DEVIATION 6.7 • n=93 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 7.2 • n=4 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 3.9 • n=27 Participants
|
|
Baseline cocaine use (days per week)
|
0.41 days
STANDARD_DEVIATION .91 • n=93 Participants
|
1.15 days
STANDARD_DEVIATION 3.84 • n=4 Participants
|
1.1 days
STANDARD_DEVIATION 1.0 • n=27 Participants
|
|
Not using cocaine at intake
Not using cocaine at intake
|
22 participants
n=93 Participants
|
19 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Not using cocaine at intake
Using cocaine at intake
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Methadone maintained
Using methadone
|
8 participants
n=93 Participants
|
14 participants
n=4 Participants
|
22 participants
n=27 Participants
|
|
Methadone maintained
not using methadone
|
17 participants
n=93 Participants
|
11 participants
n=4 Participants
|
28 participants
n=27 Participants
|
|
Any lifetime major depressive episode
History of MDD
|
4 participants
n=93 Participants
|
3 participants
n=4 Participants
|
7 participants
n=27 Participants
|
|
Any lifetime major depressive episode
No history of MDD
|
21 participants
n=93 Participants
|
22 participants
n=4 Participants
|
43 participants
n=27 Participants
|
|
Social phobia
History of social phobia
|
5 participants
n=93 Participants
|
1 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Social phobia
No history of social phobia
|
20 participants
n=93 Participants
|
24 participants
n=4 Participants
|
44 participants
n=27 Participants
|
|
Obsessive compulsive disorder
yes
|
4 participants
n=93 Participants
|
0 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Obsessive compulsive disorder
no
|
21 participants
n=93 Participants
|
25 participants
n=4 Participants
|
46 participants
n=27 Participants
|
|
Generalized anxiety disorder
yes
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Generalized anxiety disorder
no
|
19 participants
n=93 Participants
|
17 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Post-traumatic stress disorder
yes
|
5 participants
n=93 Participants
|
6 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Post-traumatic stress disorder
no
|
20 participants
n=93 Participants
|
19 participants
n=4 Participants
|
39 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Weekly measurements, Baseline to 12 weeksPopulation: intent-to-treat
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Mean Number of Days Per Week of Cocaine Use
Week 10
|
0.64 number of days per week of cocaine use
Standard Deviation 1.68
|
0.31 number of days per week of cocaine use
Standard Deviation 0.89
|
|
Mean Number of Days Per Week of Cocaine Use
Baseline
|
0.41 number of days per week of cocaine use
Standard Deviation 0.91
|
1.15 number of days per week of cocaine use
Standard Deviation 3.84
|
|
Mean Number of Days Per Week of Cocaine Use
Week 5
|
0.52 number of days per week of cocaine use
Standard Deviation 1.02
|
0.60 number of days per week of cocaine use
Standard Deviation 1.62
|
|
Mean Number of Days Per Week of Cocaine Use
Week 6
|
0.52 number of days per week of cocaine use
Standard Deviation 1.13
|
0.53 number of days per week of cocaine use
Standard Deviation 1.41
|
|
Mean Number of Days Per Week of Cocaine Use
Week 7
|
0.56 number of days per week of cocaine use
Standard Deviation 1.30
|
0.46 number of days per week of cocaine use
Standard Deviation 1.18
|
|
Mean Number of Days Per Week of Cocaine Use
Week 8
|
0.59 number of days per week of cocaine use
Standard Deviation 1.37
|
0.41 number of days per week of cocaine use
Standard Deviation 1.04
|
|
Mean Number of Days Per Week of Cocaine Use
Week 9
|
0.62 number of days per week of cocaine use
Standard Deviation 1.55
|
0.36 number of days per week of cocaine use
Standard Deviation 0.92
|
|
Mean Number of Days Per Week of Cocaine Use
Week 11
|
0.67 number of days per week of cocaine use
Standard Deviation 1.91
|
0.28 number of days per week of cocaine use
Standard Deviation 0.76
|
|
Mean Number of Days Per Week of Cocaine Use
Week 12
|
0.70 number of days per week of cocaine use
Standard Deviation 2.11
|
0.24 number of days per week of cocaine use
Standard Deviation 0.68
|
|
Mean Number of Days Per Week of Cocaine Use
Week 1
|
0.43 number of days per week of cocaine use
Standard Deviation 0.88
|
1.01 number of days per week of cocaine use
Standard Deviation 3.15
|
|
Mean Number of Days Per Week of Cocaine Use
Week 2
|
0.45 number of days per week of cocaine use
Standard Deviation 0.89
|
0.89 number of days per week of cocaine use
Standard Deviation 2.51
|
|
Mean Number of Days Per Week of Cocaine Use
Week 3
|
0.47 number of days per week of cocaine use
Standard Deviation 0.91
|
0.78 number of days per week of cocaine use
Standard Deviation 2.16
|
|
Mean Number of Days Per Week of Cocaine Use
Week 4
|
0.49 number of days per week of cocaine use
Standard Deviation 0.94
|
0.68 number of days per week of cocaine use
Standard Deviation 1.87
|
PRIMARY outcome
Timeframe: baseline, end of trial (week 12), 3-month post-trial follow-upPopulation: intent-to-treat
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
Baseline
|
0.5200 days of cocaine use between visits
Interval 0.1419 to 1.9062
|
1.6800 days of cocaine use between visits
Interval 0.5983 to 4.7171
|
|
Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
End of Trial (Week 12)
|
0.2860 days of cocaine use between visits
Interval 0.1237 to 0.6609
|
0.05550 days of cocaine use between visits
Interval 0.009978 to 0.3087
|
|
Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
3-Month Post-Trial Follow-Up
|
12.8472 days of cocaine use between visits
Interval 5.3751 to 30.7066
|
1.3659 days of cocaine use between visits
Interval 0.2618 to 7.1263
|
PRIMARY outcome
Timeframe: weekly measurements, baseline to 12 weeksPopulation: intent-to-treat
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Proportion of Positive Urine Samples Per Week
Baseline
|
0.2645 proportion of positive urines per week
Interval 0.1278 to 0.4688
|
0.1990 proportion of positive urines per week
Interval 0.0882 to 0.3893
|
|
Proportion of Positive Urine Samples Per Week
Week 1
|
0.2667 proportion of positive urines per week
Interval 0.1366 to 0.4554
|
0.2006 proportion of positive urines per week
Interval 0.0928 to 0.381
|
|
Proportion of Positive Urine Samples Per Week
Week 2
|
0.2689 proportion of positive urines per week
Interval 0.1448 to 0.4443
|
0.2022 proportion of positive urines per week
Interval 0.0969 to 0.3745
|
|
Proportion of Positive Urine Samples Per Week
Week 3
|
0.2712 proportion of positive urines per week
Interval 0.1519 to 0.436
|
0.2038 proportion of positive urines per week
Interval 0.1003 to 0.3702
|
|
Proportion of Positive Urine Samples Per Week
Week 4
|
0.2734 proportion of positive urines per week
Interval 0.1576 to 0.4309
|
0.2054 proportion of positive urines per week
Interval 0.1029 to 0.3681
|
|
Proportion of Positive Urine Samples Per Week
Week 5
|
0.2757 proportion of positive urines per week
Interval 0.1613 to 0.4296
|
0.2071 proportion of positive urines per week
Interval 0.1047 to 0.3685
|
|
Proportion of Positive Urine Samples Per Week
Week 7
|
0.2803 proportion of positive urines per week
Interval 0.1623 to 0.439
|
0.2104 proportion of positive urines per week
Interval 0.1051 to 0.3768
|
|
Proportion of Positive Urine Samples Per Week
Week 9
|
0.2849 proportion of positive urines per week
Interval 0.1553 to 0.4633
|
0.2138 proportion of positive urines per week
Interval 0.1017 to 0.3949
|
|
Proportion of Positive Urine Samples Per Week
Week 10
|
0.2872 proportion of positive urines per week
Interval 0.1496 to 0.4799
|
0.2154 proportion of positive urines per week
Interval 0.0989 to 0.4071
|
|
Proportion of Positive Urine Samples Per Week
Week 6
|
0.2780 proportion of positive urines per week
Interval 0.1629 to 0.4323
|
0.2087 proportion of positive urines per week
Interval 0.1054 to 0.3714
|
|
Proportion of Positive Urine Samples Per Week
Week 8
|
0.2826 proportion of positive urines per week
Interval 0.1597 to 0.4494
|
0.2121 proportion of positive urines per week
Interval 0.1038 to 0.3847
|
|
Proportion of Positive Urine Samples Per Week
Week 11
|
0.2895 proportion of positive urines per week
Interval 0.1429 to 0.4989
|
0.2171 proportion of positive urines per week
Interval 0.0956 to 0.4213
|
|
Proportion of Positive Urine Samples Per Week
Week 12
|
0.2918 proportion of positive urines per week
Interval 0.1356 to 0.5198
|
0.2189 proportion of positive urines per week
Interval 0.0918 to 0.4372
|
PRIMARY outcome
Timeframe: baseline, end of trial (week 12) and 3-month post-trial follow-upPopulation: intent-to-treat
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Proportion of Positive Urine Samples Per Week
Week 12
|
0.3173 proportion of positive urines per week
Interval 0.1606 to 0.5303
|
0.1904 proportion of positive urines per week
Interval 0.0758 to 0.4028
|
|
Proportion of Positive Urine Samples Per Week
Baseline
|
0.2400 proportion of positive urines per week
Interval 0.112 to 0.4416
|
0.1582 proportion of positive urines per week
Interval 0.0559 to 0.3733
|
|
Proportion of Positive Urine Samples Per Week
3 month post-trial follow-up
|
0.3952 proportion of positive urines per week
Interval 0.2189 to 0.6037
|
0.2246 proportion of positive urines per week
Interval 0.0852 to 0.474
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: intent-to-treat
To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group
|
11 adverse events
|
15 adverse events
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: intent-to-treat
CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Baseline
|
1.5630 units on a scale
Interval 1.2953 to 1.886
|
1.6752 units on a scale
Interval 1.3609 to 2.062
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 1
|
1.5456 units on a scale
Interval 1.3073 to 1.8275
|
1.6532 units on a scale
Interval 1.3616 to 2.0073
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 2
|
1.5285 units on a scale
Interval 1.3161 to 1.7751
|
1.6316 units on a scale
Interval 1.3594 to 1.9583
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 3
|
1.5115 units on a scale
Interval 1.3205 to 1.7301
|
1.6102 units on a scale
Interval 1.3536 to 1.9154
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 4
|
1.4947 units on a scale
Interval 1.3189 to 1.6939
|
1.5891 units on a scale
Interval 1.3438 to 1.8791
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 5
|
1.4781 units on a scale
Interval 1.3097 to 1.6681
|
1.5683 units on a scale
Interval 1.3297 to 1.8497
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 7
|
1.4454 units on a scale
Interval 1.2678 to 1.6478
|
1.5275 units on a scale
Interval 1.2883 to 1.8111
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 8
|
1.4293 units on a scale
Interval 1.2374 to 1.651
|
1.5075 units on a scale
Interval 1.2619 to 1.8009
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 9
|
1.4134 units on a scale
Interval 1.2032 to 1.6604
|
1.4877 units on a scale
Interval 1.2325 to 1.7957
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 10
|
1.3977 units on a scale
Interval 1.1668 to 1.6744
|
1.4682 units on a scale
Interval 1.201 to 1.7949
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 11
|
1.3822 units on a scale
Interval 1.1292 to 1.6919
|
1.4490 units on a scale
Interval 1.1681 to 1.7975
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 12
|
1.3668 units on a scale
Interval 1.0914 to 1.7118
|
1.4300 units on a scale
Interval 1.1342 to 1.803
|
|
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Week 6
|
1.4616 units on a scale
Interval 1.2925 to 1.653
|
1.5478 units on a scale
Interval 1.3111 to 1.8271
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: intent-to-treat
EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 1
|
8.05 units on a scale
Standard Error 1.37
|
8.61 units on a scale
Standard Error 1.41
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 2
|
8.57 units on a scale
Standard Error 1.19
|
6.65 units on a scale
Standard Error 1.03
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 4
|
9.27 units on a scale
Standard Error 1.60
|
6.62 units on a scale
Standard Error 1.08
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 5
|
7.60 units on a scale
Standard Error 1.54
|
6.62 units on a scale
Standard Error 1.09
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 6
|
8.05 units on a scale
Standard Error 1.52
|
7.24 units on a scale
Standard Error 1.48
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 7
|
9.13 units on a scale
Standard Error 1.71
|
6.53 units on a scale
Standard Error 1.41
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 8
|
8.29 units on a scale
Standard Error 1.64
|
6.16 units on a scale
Standard Error 1.48
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 9
|
8.24 units on a scale
Standard Error 1.70
|
6.68 units on a scale
Standard Error 1.77
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 10
|
8.55 units on a scale
Standard Error 1.69
|
6.64 units on a scale
Standard Error 1.33
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Baseline
|
10.84 units on a scale
Standard Error 1.37
|
11.08 units on a scale
Standard Error 1.44
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 3
|
6.91 units on a scale
Standard Error 1.04
|
6.95 units on a scale
Standard Error 1.41
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 11
|
7.33 units on a scale
Standard Error 1.43
|
6.85 units on a scale
Standard Error 1.40
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Week 12
|
8.38 units on a scale
Standard Error 1.71
|
6.60 units on a scale
Standard Error 1.15
|
|
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
3-month post trial
|
9.09 units on a scale
Standard Error 1.43
|
7.21 units on a scale
Standard Error 1.32
|
SECONDARY outcome
Timeframe: week 2, week 6, week 10, week 12Population: intent-to-treat
A comparison of salivary progesterone concentrations across all samples for all timepoints
Outcome measures
| Measure |
Placebo
n=25 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Salivary Progesterone Concentrations
Week 6
|
189.38 pg/ml of salivary progesterone
Standard Error 237.94
|
1580.95 pg/ml of salivary progesterone
Standard Error 1963.51
|
|
Salivary Progesterone Concentrations
Week 10
|
124.30 pg/ml of salivary progesterone
Standard Error 72.31
|
1771.07 pg/ml of salivary progesterone
Standard Error 3139.36
|
|
Salivary Progesterone Concentrations
Week 12
|
235.04 pg/ml of salivary progesterone
Standard Error 288.51
|
866.10 pg/ml of salivary progesterone
Standard Error 1044.84
|
|
Salivary Progesterone Concentrations
Week 2
|
165.94 pg/ml of salivary progesterone
Standard Error 135.30
|
797.26 pg/ml of salivary progesterone
Standard Error 1004.13
|
POST_HOC outcome
Timeframe: baseline to 12 weeksPopulation: intent-to-treat
Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=19 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Relapse to Cocaine Use During Treatment Period
|
9 participants who relapsed to cocaine use
|
3 participants who relapsed to cocaine use
|
POST_HOC outcome
Timeframe: baseline to 3 months post 12-week trial periodPopulation: intent-to-treat
Post-hoc sensitivity test to compare hazard of relapse to cocaine use between two treatment groups among participants (n=41) who did not report using cocaine at intake.
Outcome measures
| Measure |
Placebo
n=22 Participants
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=19 Participants
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
Relapse to Cocaine Use During Treatment Period or 3 Months Post Treatment
|
10 participants who relapsed to cocaine use
|
4 participants who relapsed to cocaine use
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Progesterone
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=25 participants at risk
Matched placebo pills to be taken twice daily
Placebo: Matched placebo pills to be taken twice daily
|
Progesterone
n=25 participants at risk
100 mgs progesterone twice daily
Progesterone: 100mgs progesterone twice daily
|
|---|---|---|
|
General disorders
Headache
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
24.0%
6/25 • Number of events 6 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
|
General disorders
Sedation
|
16.0%
4/25 • Number of events 4 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
16.0%
4/25 • Number of events 4 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
|
General disorders
Dizziness
|
0.00%
0/25 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
|
General disorders
Dry mouth
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
0.00%
0/25 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
|
General disorders
Nausea
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected over the entire study period, from the intake of the participants to their final 3-month follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place