Trial Outcomes & Findings for Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS) (NCT NCT00151411)
NCT ID: NCT00151411
Last Updated: 2018-03-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2018-03-21
Participant Flow
Participant milestones
| Measure |
Metformin
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
|
Placebo
Placebo (2 tablets twice a day) initiated in a step-up fashion
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
59
|
|
Overall Study
COMPLETED
|
22
|
16
|
|
Overall Study
NOT COMPLETED
|
33
|
43
|
Reasons for withdrawal
| Measure |
Metformin
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
|
Placebo
Placebo (2 tablets twice a day) initiated in a step-up fashion
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
19
|
|
Overall Study
Withdrawal by Subject
|
12
|
20
|
|
Overall Study
Adverse Event
|
6
|
0
|
|
Overall Study
Pregnancy
|
0
|
4
|
Baseline Characteristics
Lifestyle Intervention and Metformin for Women With Polycystic Ovary Syndrome (PCOS)
Baseline characteristics by cohort
| Measure |
Metformin
n=55 Participants
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
|
Placebo
n=59 Participants
Placebo (2 tablets twice a day) initiated in a step-up fashion
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 4.5 • n=93 Participants
|
28.8 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
28.9 years
STANDARD_DEVIATION 4.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=93 Participants
|
59 participants
n=4 Participants
|
114 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsOutcome measures
| Measure |
Metformin
n=55 Participants
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
|
Placebo
n=59 Participants
Placebo (2 tablets twice a day) initiated in a step-up fashion
|
|---|---|---|
|
Change in Testosterone After 6 Months of Treatment
|
-2.1 ng/dL
Interval -12.1 to 7.9
|
-6.4 ng/dL
Interval -16.9 to 4.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: A total of 76 patients with daily urine collections.
Count of ovulations per subject during the treatment period.
Outcome measures
| Measure |
Metformin
n=37 Participants
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
|
Placebo
n=39 Participants
Placebo (2 tablets twice a day) initiated in a step-up fashion
|
|---|---|---|
|
Ovulation Rate
1 ovulation
|
6 Participants
|
5 Participants
|
|
Ovulation Rate
0 ovulations
|
10 Participants
|
19 Participants
|
|
Ovulation Rate
2 ovulations
|
4 Participants
|
7 Participants
|
|
Ovulation Rate
3 ovulations
|
7 Participants
|
3 Participants
|
|
Ovulation Rate
4 ovulations
|
4 Participants
|
2 Participants
|
|
Ovulation Rate
5 ovulations
|
1 Participants
|
0 Participants
|
|
Ovulation Rate
6+ ovulations
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline and 6 monthsOutcome measures
| Measure |
Metformin
n=55 Participants
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
|
Placebo
n=59 Participants
Placebo (2 tablets twice a day) initiated in a step-up fashion
|
|---|---|---|
|
Change in Insulin Sensitivity Index After 6 Months of Treatment
|
1.9 index
Interval -1.0 to 4.8
|
-2.7 index
Interval -6.2 to 0.9
|
Adverse Events
Metformin
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metformin
n=55 participants at risk
Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
|
Placebo
n=59 participants at risk
Placebo (2 tablets twice a day) initiated in a step-up fashion
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
34.5%
19/55 • Number of events 78
|
10.2%
6/59 • Number of events 22
|
|
Gastrointestinal disorders
stomach/abdominal pain or discomfort
|
10.9%
6/55 • Number of events 9
|
11.9%
7/59 • Number of events 16
|
|
Gastrointestinal disorders
nausea and/or vomiting
|
16.4%
9/55 • Number of events 27
|
11.9%
7/59 • Number of events 18
|
|
Gastrointestinal disorders
flatulence
|
3.6%
2/55 • Number of events 5
|
5.1%
3/59 • Number of events 3
|
|
Gastrointestinal disorders
flu
|
14.5%
8/55 • Number of events 12
|
6.8%
4/59 • Number of events 4
|
|
Infections and infestations
common cold/respiratory tract infection
|
21.8%
12/55 • Number of events 23
|
22.0%
13/59 • Number of events 19
|
|
Nervous system disorders
dizziness
|
5.5%
3/55 • Number of events 5
|
5.1%
3/59 • Number of events 3
|
|
Nervous system disorders
headache/migraine
|
21.8%
12/55 • Number of events 42
|
18.6%
11/59 • Number of events 16
|
|
Nervous system disorders
fatigue
|
3.6%
2/55 • Number of events 2
|
6.8%
4/59 • Number of events 4
|
|
Nervous system disorders
altered mood/mood swings
|
0.00%
0/55
|
8.5%
5/59 • Number of events 6
|
|
Reproductive system and breast disorders
dysmenorrhea/cramps
|
12.7%
7/55 • Number of events 14
|
15.3%
9/59 • Number of events 19
|
|
Reproductive system and breast disorders
vaginal infection
|
5.5%
3/55 • Number of events 3
|
5.1%
3/59 • Number of events 3
|
|
Renal and urinary disorders
bladder infection
|
1.8%
1/55 • Number of events 2
|
5.1%
3/59 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
9.1%
5/55 • Number of events 7
|
15.3%
9/59 • Number of events 17
|
|
General disorders
hair loss
|
5.5%
3/55 • Number of events 3
|
0.00%
0/59
|
|
General disorders
allergic reaction
|
0.00%
0/55
|
5.1%
3/59 • Number of events 3
|
|
General disorders
dental issues
|
5.5%
3/55 • Number of events 4
|
1.7%
1/59 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place