Comparison of vaginal estrogen cream and tibolone in urogenital syndrome of menopause

All subjects will undergo thorough clinical history regarding demographic profile the menopausal symptoms and any long-term medications etc. and will undergo clinical examination including BMI and waist circumference, breast examination, and pelvic examination and data will be entered on preformed attached proforma [9]. Complete blood picture, urine test routine/microscopy, fasting glucose level/Hb1Ac, lipid profile, serum TSH, stool for occult blood, PAP smear, vaginal pH, TVS, mammogram if breast lump will be found on examination will be conducted in each case before starting the study. Urogenital symptoms will be rated on a Menopausal Rating Scale before starting the treatment and after 3 months of treatment. Vaginal Health Index (VHI), vaginal Ph (performed from swab collected from lateral vaginal wall) and vaginal maturation index. Sample for smear will be taken from lateral vaginal wall) will be observed before starting the treatment and will be re-evaluated again after completing 3 months treatment [9]. The subjects will be randomized in 2 groups – Group 1- Will receive Estriol vaginal cream 0.1% 0.5 mg daily for 15 days in night and     then 0.3 mg twice weekly in nights for 2 months 15 days. Group 2 - Will receive Tab. Tibolone 2.5 mg daily for 3 months Subjects will be followed for improvement in symptoms and for adverse effects at 1 monthly interval in both the groups. Assessment of symptomatic relief of most bothersome symptoms of GSM, side effect of medications ( nausea, vomiting, breakthrough bleeding, breast tenderness), VHI, vaginal Ph, and VMI will be done after completion of 3 months treatment.