Trial of Mifepristone for Fibroids
Randomized Control Trial Of Mifepristone for Fibroids
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
A PHASE3 clinical study on Leiomyoma, this trial is completed. The trial is conducted by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and has accumulated 9 data snapshots since 2003. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.
This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.
Status Flow
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Present [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Oct 2023 — Jul 2024 [monthly]
Completed PHASE3
-
Dec 2021 — Oct 2023 [monthly]
Completed PHASE3
▶ Show 4 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jul 2003
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- University of Rochester
For direct contact, visit the study record on ClinicalTrials.gov .