Health Condition 1: null- Menopausal women experiencing vasomotor symptoms/vaginal atrophy
Conditions
Interventions
Intervention1: Micronized Estradiol Valerate (0.5 mg) tablets: 1. Micronized Estradiol Valertae (0.5 mg), continously for 24 weeks in hysterectomized women
2. In women with intact uterus, a continous
Sponsors
Walter Bushnell Pvt Ltd
Eligibility
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I) Improvement in Vasomotor symptoms (Hot flushes) â?¢ Frequency (No. of hot flushes per 4 weeks, 12 weeks and 24 weeks) and severity of hot flushes (Mild, Moderate, Severe) II) Improvement in vaginal health â?¢ Symptom relief (Genital and urinary symptoms â?¢ Vaginal Health index-(Pre and post-therapy)Timepoint: 0, 4, 12 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Bodyweight/BMITimepoint: After 24 weeks of therapy;Endometrial thickness by TVSTimepoint: After 24 weeks of therapy;Hormone profile (FSH and E2 levels) Timepoint: After 24 weeks of therapy;Lipid profileTimepoint: After 24 weeks of therapy;Liver function profileTimepoint: After 24 weeks of therapy;Quality of menopausal life by Greene Climacteric ScaleTimepoint: After 24 weeks of therapy;TSH levelsTimepoint: After 24 weeks of therapy | — |
Countries
India
Contacts
Public ContactDr Prof Renuka Sinha
VMMC & Safdarjung Hospital
Outcome results
None listed