Ormeloxifene: a better therapeutic option than Medroxyprogesterone Acetate in perimenopausal women with abnormal uterine bleeding.
Not Applicable
- Conditions
- Health Condition 1: N920- Excessive and frequent menstruation with regular cycle
- Registration Number
- CTRI/2019/09/021275
- Lead Sponsor
- ivedita Chawla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All perimenopausal females between the age of 39 to 51 years with abnormal uterine bleeding.
Exclusion Criteria
a.Pregnancy
b.Organic Pelvic Pathology like polyp, fibroid, adenomyosis, endometriosis
c.Systemic Pathology
d.Coagulation disorders
e.Breast malignancy
f.Endometrial Hyperplasia with atypia
g.Endocrine disorders like hypothyroidism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effectiveness of Ormeloxifene vs Medroxyprogesterone Acetate in cases of abnormal uterine bleeding in perimenopausal women.Timepoint: Follow up will be done at 2nd month, 4th month and 6th month
- Secondary Outcome Measures
Name Time Method â?¢To study the effectiveness of Ormeloxifene in AUB in perimenopausal women. <br/ ><br>â?¢To study the effectiveness of Medroxyprogesterone Acetate in AUB in perimenopausal women. <br/ ><br>â?¢To compare Ormeloxifene versus Medroxyprogesterone Acetate in terms of PBAC Score, endometrial thickness by TVS, rise in haemoglobin and hematocrit AUB in perimenopausal women. <br/ ><br>At 2nd month symptomatic improvement, PBAC score and side effects will be assessed.Timepoint: 2nd, 4th and 6th month.