Uterine fibroids
Conditions
Interventions
Treatment Group 1:Three months of daily therapy with oral mifepristone (at a dose of 10 mg)
Treatment Group 2:Three months of daily therapy with oral mifepristone (at a dose of 25 mg)
Control Group:once-monthly subcutaneous injections of enantone (at a dose of 3.75 mg)
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. uterine size equivalent to at least 10 weeks of gestation in a gravid uterus; 2. if the uterine size did not reached to 10 weeks gestation, patients had one or more of following symptoms including menorrhagia, dysmenorrhea, pelvic pressure, or anemia; 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 10. allergic to GnRH-a class of drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in volume of the largest uterine fibroid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in anemia, including improvement of hemoglobin, red blood cell count and hematocrit.;Changes in relevant symptom, ie, percentage of subjects with amenorrhea, dysmenorrhea, pressure-related symptoms, non-menstrual abdominal pain, menstrual blood loss; | — |
Countries
China
Contacts
Public ContactZheng Shurong
Outcome results
None listed