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

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

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

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 months

Population: 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 months

Population: 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

Dr. John Nestler

Virginia Commonwealth University

Phone: 804-828-3389

Results disclosure agreements

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