Trial Outcomes & Findings for Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study) (NCT NCT01718444)

Results Overview

Delivery of a viable infant after 24 weeks of pregnancy

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Within 36 weeks of a positive pregnancy test

Results posted on

2020-09-29

Participant Flow

The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.

Participant milestones

Participant milestones
Measure	Group A (No PIES) Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course. * CC 50 mg oral for 5 days ("Days 3-7") * If no ovulation, CC 100 mg for 5 days ("Days 12-16") * If no ovulation, CC 150 mg for 5 days ("Day 21-25") * Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles Clomiphene Citrate	Group B (PIES Group) Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC) * Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES) * CC 50 mg oral for 5 days (Day 3-7) * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses * If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days * Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles Progestin Clomiphene Citrate
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Within 36 weeks of a positive pregnancy test

Population: The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.

Delivery of a viable infant after 24 weeks of pregnancy

Outcome measures

Outcome data not reported

Adverse Events

Group A (No PIES)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B (PIES Group)

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

Albert Asante, MD MPH

UIC

Phone: 3123552634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place