Drug treatment with mifepristone for management of uterine fibroids
- Conditions
- Health Condition 1: D251- Intramural leiomyoma of uterusHealth Condition 2: D250- Submucous leiomyoma of uterusHealth Condition 3: D252- Subserosal leiomyoma of uterusHealth Condition 4: null- Women with symptomatic fibroids
- Registration Number
- CTRI/2018/06/014616
- Lead Sponsor
- Department of obstetrics and gynaecology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
1.Symptomatic fibroid cases, measuring at least 3 cm exhibiting heavy menstrual bleeding or dysmenorrhoea or pelvic pressure 2.Those giving consent
3.Accepting the use of non-hormonal contraceptive
4.Agreeing to endometrial biopsy if needed
1.currently planning pregnancy during study period
2.menopausal
3.currently breastfeeding
4.adnexal mass or endometriosis
5. coagulation dysfunction or bleeding tendencies
6.severe anemia <5 g% or needing blood transfusion
7.current or recent (within 3 months) use of oral / systemic corticosteroids or mifepristone
8.use within past 6 months of GnRH analogues
9.any contraindication to receive anti-progestins
10.any history or suspicion of breast cancer or other genital malignancy
11.laboratory findings that give any suspicion of blood, liver or renal dysfunction
12.those not giving consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method