Trial Outcomes & Findings for Pilot Study:Role of Dietary Fiber in PCOS Anovulation (NCT NCT00703092)
NCT ID: NCT00703092
Last Updated: 2017-10-09
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
10 months
Results posted on
2017-10-09
Participant Flow
Participant milestones
| Measure |
Fiber-Stat
2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Fiber-Stat
2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Pilot Study:Role of Dietary Fiber in PCOS Anovulation
Baseline characteristics by cohort
| Measure |
Fiber-Stat
n=2 Participants
2 tablespoons daily
Fiber-Stat: Liquid fiber supplement, 2 tablespoons twice daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 monthsPopulation: This study was terminated early due to lack of enrollment. No assays were run so there is no data to report.
Outcome measures
Outcome data not reported
Adverse Events
Fiber-Stat
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place