Comparison of different Estrogen preparations for improvement of vasomotor symptoms/Vaginal atrophy in Indian menopausal wome
- Conditions
- Health Condition 1: null- Menopausal women experiencing vasomotor symptoms/vaginal atrophy
- Registration Number
- CTRI/2012/04/002566
- Lead Sponsor
- Walter Bushnell Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Menopausal women upto 70 years of age
2.Symptomatic women with natural menopause
3.Hysterectomised women with one or both ovaries preserved, considered only if serum FSH >40 IU/L and serum estradiol < 20 IU/L
4.Women with bilateral oophrectomy
5.Women with menopause due to premature ovarian failure
6.Amenorrhoea for more than 1 year
7.Currently experiencing vasomotor symptoms i.e hot flushes, night sweats, insomnia, sleep disturbances
8.Currently experiencing dyspareunia, urinary symptoms such as frequency, urgency, dysuria, burning micturition, incontinence etc.
1.Tobacco or alcohol abuser.
2.History of malignant diseases.
3.Abnormal mammogram within two years of study entry
4.History of hormone dependent tumors
5.Women with chronic diseases, such as uncontrolled hypertension; diabetes; liver, kidney and thyroid dysfunction
6.Women on Long-term therapy such as Antiepileptic drugs or Diuretics
7.Prior intake of hormonal medications within the 3 months
8.Women with history of thrombophlebitis, estrogen-related thrombosis or thromboembolism, Cerebrovascular accident, with known or suspected estrogen-dependent tumor, undiagnosed vaginal bleeding, Migraine, Uterine disorders, Breast disorders, Gallbladder disease, Areterial thrombosis and Hypercholesterolemia
9.Obese women: BMI36
10.Known hypersensitivity to drugs used in the study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method