Trial Outcomes & Findings for Trial of Mifepristone for Fibroids (NCT NCT00133705)

Results Overview

Uterine volume is measured in mLs

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

70 participants

Primary outcome timeframe

6 months

Results posted on

2023-09-25

Women were recruited between March 3, 2004 and March 30, 2005 through local media and contacts with community physicians.

38 women were deemed ineligible. Of those exclusion criteria applied to 27 and 11 declined participation.

Participant milestones
Measure	Treatment Group This group will receive 5 mg. capsules to be taken once daily.	Placebo Group These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
Overall Study STARTED	22	20
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal
Measure	Treatment Group This group will receive 5 mg. capsules to be taken once daily.	Placebo Group These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
Overall Study Withdrawal by Subject	2	3

Trial of Mifepristone for Fibroids

Baseline characteristics by cohort
Measure	Mifepristone 5 mg. n=22 Participants Twenty-two women received 5 mg. mifepristone daily.	Placebo n=20 Participants Twenty women received a placebo pill daily.	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42.8 years STANDARD_DEVIATION 6.2 • n=5 Participants	43.2 years STANDARD_DEVIATION 4.7 • n=7 Participants	43.0 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

Timeframe: 6 months

Uterine volume is measured in mLs

Outcome measures
Measure	Treatment Group n=22 Participants This group will receive 5 mg. capsules to be taken once daily.	Placebo Group n=20 Participants These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
Uterine Volume	719 mL Standard Deviation 663	449 mL Standard Deviation 236

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Rochester

Phone: 585-271-1206