Health Condition 1: D259- Leiomyoma of uterus, unspecified
Conditions
Interventions
Intervention1: Tab Mifepristone: 10 mg tablet will be given once daily for period of three months
Intervention2: Tablet Mifepristone: Dose of 25 mg to be given once daily for three months (based on cl
Sponsors
Jyotsna Puri
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women between 20-50 years of age with single or multiple fibroids 2. Symptomatic (menorrhagia, polymenorrhea, dysmenorrhoea, abdominal lump, dull aching lower abdominal pain, dyspareunia) or 3. Asymptomatic
Exclusion criteria
Exclusion criteria: 1. USG suggestive of adenomyosis, endometriosis adnexal mass for the above symptoms. 2. More than 16-week gravid size uterus 3. Fibroids greater than 10 cm by ultrasound 4. Renal or hepatic dysfunction 5. Current genital infection 6. Endometrial hyperplasia with atypia 7. Hormonal medication (Progestogens or GnRH) within 3 months 8. Women desiring pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Reduction in symptoms after treatment in both groups 2.Change in Quality of life as assessed by Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire after treatment 3.Change in PBAC and Hemoglobin among both the groups 4.Change in size of uterine myoma on USG Timepoint: at baseline and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of Adverse effectsTimepoint: At 3 moths | — |
Countries
India
Contacts
Public ContactJyotsna Puri
Maharaja Agrasen Hospital
Outcome results
None listed