Uterine fibroids
Conditions
Interventions
Treatment Group:started from 1-3 days of the menstrual cycle, one tablet of 10 mg mifepristone taken orally every day for 84 days
Control Group:started from 1-3 days of the menstrual cycle, one placebo tablet taken orally every day for 3 months
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. at least one fibroid that was 3 cm or more in diameter, but with no fibroid measuring more than 7 cm in diameter (equivalent to 14-180 cm3 in volume), as measured by ultrasonography; 2. indication for surgery (hysterectomy or myomectomy), and 3. providing informed consent form.
Exclusion criteria
Exclusion criteria: 1. Postmenopausal; 2. submucosal fibroids; 3. suspicion or diagnosis of uterine or endometrial malignancy; 4. adnexal mass or endometriosis; 5. coagulation dysfunction and bleeding tendencies; 6. severe anemia, defined as a hemoglobin level lower than 6g per deciliter; 7. suspicion or diagnosis of pregnant or breastfeeding; 8. hepatic or renal malfunction; 9. received mifepristone therapy in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in volume of the largest uterine fibroid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in anemia, including RBC, hemoglobin and hematocrit;Changes in relevant symptoms, i.e., percentage of subjects with amenorrhea, dysmenorrhea, pelvic pressure, non-menstrual abdominal pain, menstrual blood loss; | — |
Countries
China
Contacts
Public ContactZheng Shurong
Outcome results
None listed