CTRI/2012/04/002566
Completed
Phase 4
A study to compare the symptomatic response in Indian menopausal women with different Estrogen preparations for treatment of vasomotor symptoms/vaginal atrophy
Walter Bushnell Pvt Ltd0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Walter Bushnell Pvt Ltd
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
The effect of voice therapy in improving voice quality in teachersMuscle tension dysphonia.Other voice and resonance disordersIRCT20170922036319N2Tehran University of Medical Sciences24
Completed
Not Applicable
A Study for the investigation of symptomatic improvement and safety of INJUV ingestion in individuals with knee and low back pai/A (healthy adults)JPRN-UMIN000026460Anti-Aging Bank Co.,Ltd.12
Withdrawn
Not Applicable
Comparative study on the Inflammatory Response after Endovascular Aortic aneurysm Repair and Endovascular Aneurysm SealingNL-OMON46674Rijnstate Ziekenhuis30
Completed
Not Applicable
Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomasJPRN-UMIN000035557ippon Medical School Hospital76
Completed
Phase 2
Response to treatment in patients with chronic hepatitis C genotype and drug sovodak newly diagnosed patients with previous treatment failureIRCT201702016388N7Vice Chancellor for Research of Tabriz University of Medical Sciences50