Trial Outcomes & Findings for Progesterone Treatment for Cocaine-dependent Women: A Pilot Study (NCT NCT00632099)
NCT ID: NCT00632099
Last Updated: 2014-05-12
Results Overview
Percentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
21 participants
Primary outcome timeframe
during last 3 weeks of the trial
Results posted on
2014-05-12
Participant Flow
Participant milestones
| Measure |
Matched Placebo
matched placebo
Placebo: matched placebo
|
Oral Micronized Progesterone
Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Matched Placebo
matched placebo
Placebo: matched placebo
|
Oral Micronized Progesterone
Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Progesterone Treatment for Cocaine-dependent Women: A Pilot Study
Baseline characteristics by cohort
| Measure |
Matched Placebo
n=10 Participants
matched placebo
Placebo: matched placebo
|
Oral Micronized Progesterone
n=11 Participants
Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 9 • n=99 Participants
|
45 years
STANDARD_DEVIATION 8 • n=107 Participants
|
43 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: during last 3 weeks of the trialPercentage of patients cocaine abstinent during last 3 weeks of the study (weeks 7-9)
Outcome measures
| Measure |
Matched Placebo
n=10 Participants
matched placebo
Placebo: matched placebo
|
Oral Micronized Progesterone
n=11 Participants
Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
|
|---|---|---|
|
Cocaine Abstinence Based on Urine Toxicology Results
|
1 participants
|
3 participants
|
Adverse Events
Matched Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Oral Micronized Progesterone
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Matched Placebo
n=10 participants at risk
matched placebo
Placebo: matched placebo
|
Oral Micronized Progesterone
n=11 participants at risk
Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
|
|---|---|---|
|
Eye disorders
Uveitis
|
0.00%
0/10 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
Other adverse events
| Measure |
Matched Placebo
n=10 participants at risk
matched placebo
Placebo: matched placebo
|
Oral Micronized Progesterone
n=11 participants at risk
Oral micronized progesterone (up to 400 mg/day)
Oral micronized progesterone: Oral micronized progesterone (up to 400 mg/day), suspended in olive oil
|
|---|---|---|
|
Reproductive system and breast disorders
abdominal pain/cramps
|
10.0%
1/10 • Number of events 1 • 10 weeks of study participation
|
27.3%
3/11 • Number of events 3 • 10 weeks of study participation
|
|
Reproductive system and breast disorders
breast tenderness
|
40.0%
4/10 • Number of events 4 • 10 weeks of study participation
|
18.2%
2/11 • Number of events 2 • 10 weeks of study participation
|
|
General disorders
headache
|
60.0%
6/10 • Number of events 6 • 10 weeks of study participation
|
36.4%
4/11 • Number of events 4 • 10 weeks of study participation
|
|
General disorders
fatigue
|
50.0%
5/10 • Number of events 5 • 10 weeks of study participation
|
27.3%
3/11 • Number of events 3 • 10 weeks of study participation
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.00%
0/10 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
Psychiatric disorders
depression
|
20.0%
2/10 • Number of events 2 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
Gastrointestinal disorders
nausea
|
10.0%
1/10 • Number of events 1 • 10 weeks of study participation
|
0.00%
0/11 • 10 weeks of study participation
|
|
Gastrointestinal disorders
diarrhea
|
10.0%
1/10 • Number of events 1 • 10 weeks of study participation
|
0.00%
0/11 • 10 weeks of study participation
|
|
General disorders
dizziness
|
20.0%
2/10 • Number of events 2 • 10 weeks of study participation
|
0.00%
0/11 • 10 weeks of study participation
|
|
Psychiatric disorders
anxiety
|
10.0%
1/10 • Number of events 1 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
General disorders
swollen hands
|
10.0%
1/10 • Number of events 1 • 10 weeks of study participation
|
0.00%
0/11 • 10 weeks of study participation
|
|
General disorders
increased libido
|
0.00%
0/10 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
General disorders
hot flashes
|
0.00%
0/10 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
Psychiatric disorders
irritability
|
10.0%
1/10 • Number of events 1 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
Eye disorders
eye discomfort
|
0.00%
0/10 • 10 weeks of study participation
|
18.2%
2/11 • Number of events 2 • 10 weeks of study participation
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/10 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
Gastrointestinal disorders
increased appetite
|
20.0%
2/10 • Number of events 2 • 10 weeks of study participation
|
0.00%
0/11 • 10 weeks of study participation
|
|
General disorders
dry mouth
|
0.00%
0/10 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/10 • 10 weeks of study participation
|
9.1%
1/11 • Number of events 1 • 10 weeks of study participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place