Drug treatment with mifepristone for management of uterine fibroids

Not Applicable

Completed

Conditions: Subserosal leiomyoma of uterus, (2) ICD-10 Condition: D251||Intramural leiomyoma of uterus, (3) ICD-10 Condition: D250||Submucous leiomyoma of uterus,

Registration Number: CTRI/2018/06/014616

Lead Sponsor: Department of obstetrics and gynaecology

Brief Summary: â€¢Uterine fibroids are the most common benign tumour reported to occur in about 70% women in their reproductive years and about 40% have symptoms severe enough to warrant therapy.

â€¢Medical treatment is predominantly used for preoperative correction of anaemia, size reduction and symptom management.

â€¢Mifepristone is a is a progesterone receptor modulator with primarily antagonistic properties.

â€¢In various studies mifepristone has shown to decrease size of fibroid and uterus, improve anemia and fibroid-related symptoms.

The present study is planned with the following objectives:

â€¢Primary objective: To compare the effect of 25 mg daily dose, with 50 mg biweekly mifepristone, on fibroid volume in women with symptomatic fibroids.

â€¢Secondary objective : To compare and study the effect of both the dosages on :

1. Haemoglobin levels

2. Improvement in pattern of periods

3. Any side effects would be noted to study and compare the

safety.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 70

Inclusion Criteria

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.

Exclusion Criteria

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
Fibroid volume	1.Before starting mifepristone \| 2.at end of 3 months

Secondary Outcome Measures

Name	Time	Method
1. Haemoglobin levels	2. Improvement in pattern of periods and symptoms caused by fibroids.

Trial Locations

Locations (1): Outpatient department of GMCH 32, Chandigarh.
🇮🇳
Chandigarh, CHANDIGARH, India
Outpatient department of GMCH 32, Chandigarh.
🇮🇳Chandigarh, CHANDIGARH, India
Dr Reeti Mehra
Principal investigator
9646121581
drreetidatta@yahoo.co.in