Health Condition 1: null- with fibroid uterus
Conditions
Interventions
Intervention1: Ulipristal acetate 5 mg: One tablet of 5 mg Ulipristal acetate will be taken orally once daily for two treatment courses of 13 weeks each with 5 month off treatment interval
Control In
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1 The volunteers in the age group of 18-49 years (premenopausal women) 2 Body Mass Index (BMI) >= 18 and 3 A pictorial blood-loss assessment chart (PBAC) score of >100 4 Have at least one myoma of >= 3 cm but 5 Overall uterine size not more than 18 weeks of gravid uterus.
Exclusion criteria
Exclusion criteria: a)They belonged to countries other than India. b)Below 18 years or above 49 years of age or not in premenopausal phase. c)A history of/ or current treatment of myomas. d)Genital bleeding of unknown etiology or for reasons other than uterine myomas. e)A history of/or current uterine, cervical, ovarian or breast cancer. f)A history of/or current endometrium atypical hyperplasia or adenocarcinoma. g)A history of/or current coagulation disorder, osteoporosis, renal impairment and hepatic impairment. h)A pregnancy at baseline or nursing or planning a pregnancy during the course of the study. i)A history of/or current concomitant disease potentially associated with hormonal regulation. j)Chronic intake of drugs affecting hormone levels. k)History of taking any kind of drug , afeecting hormone levels in previous three months. l)No consent for participation in the study m)A history of/or current problem with alcohol or smoking or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.PBAC Score 2.Volume of Myoma Timepoint: comparator arm baseline, 3 month , 6 month 9 month 12 month Intervention arm: baseline, 3 month , 8 month 11 month 14 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.VAS Score 2.Histopathology of Endometrial Tissue except in Unmarried women, Endometrial thickness on USG 3.Biochemical Markers: Hb, LFT, KFT, S Estradiol 4.Side effects Timepoint: comparator arm baseline, 3 month , 6 month 9 month 12 month intervention arm: baseline, 3 month , 8 month 11 month 14 month | — |
Countries
India
Contacts
Public ContactDr Ram Kumar Patidar
All India Institute of Medical Sciences
Outcome results
None listed