to compare two dose schedule of ulipristal acetate
- Conditions
- Health Condition 1: null- with fibroid uterus
- Registration Number
- CTRI/2017/09/009935
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 The volunteers in the age group of 18-49 years (premenopausal women)
2 Body Mass Index (BMI) >= 18 and <= 40 kg/m2
3 A pictorial blood-loss assessment chart (PBAC) score of >100
4 Have at least one myoma of >= 3 cm but <10cm in largest dimension
5 Overall uterine size not more than 18 weeks of gravid uterus.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method