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Atorvastatin with Mifepristone in comparison to Mifepristone in medical management of fibroid

Comparative Study Of Effect Of Atorvastatin With Mifepristone Versus Mifepristone In Medical Management Of Fibroid. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065081
Enrollment
122
Registered
2024-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: D259- Leiomyoma of uterus, unspecified

Interventions

Intervention1: Atorvastatin with Mifepristone vs Mifepristone: Two groups will be assigned, Group A and Group M.Group A will be given Tab Atorvastatin 20mg with Tab Mifepristone 25mg PER ORAL daily fo

Sponsors

Dr Riya Goyal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients in reproductive and perimenopausal age group with uterine fibroid having symptom.patients giving written informed consent.Patients who donot want surgery.

Exclusion criteria

Exclusion criteria: Patients with severe presentation of fibroid such as severe intauterine bleeding or severe dysmenorrhea.Associated uterine and adnexal pathology like ovarian,cervical or uterine malignancy and associated medical morbidity like presence of liver disease,renal disease,myopathy,pancreatitis,hypersensitivity reaction and diabetes mellitus.patient necessitating early surgical intervention for uterine leiomyoma.Hormonal contraception or any hormonal therapy in the previous three months.Post menopausal women.Not willing to participate.

Design outcomes

Primary

MeasureTime frame
To assess the effect of atorvastatin with mifepristone and mifepristone alone on the size of leiomyoma,endometrial thickness and pattern,dysmenorrhea,heavy menstrual bleeding and quality of lifeTimepoint: The following parameters are recorded at the start of the study and at the completion of three months. USG(TVS/WA) VAS PBAC QOL

Secondary

MeasureTime frame
To compare the effectiveness of Atorvastatin with Mifepristone and mifepristone alone in medical management of fibroidTimepoint: The following parameters are recorded at the start of the study and at the completion of three months. USG(TVS/WA) VAS PBAC QOL

Countries

India

Contacts

Public ContactDr Riya Goyal

Teerthanker Mahaveer Medical college and Research Centre, Moradabad

drkanchanrani@gmail.com9756216630

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026