To compare the effects of tibolone tablet versus oestradiol cream applied on the skin, on blood calcium and 25-hydroxy vitamin D levels after surgical menopause.
Not Applicable
- Conditions
- Health Condition 1: null- SURGICALLY MENOPAUSAL WOMEN WITH MENOPAUSAL SYMPTOMS
- Registration Number
- CTRI/2013/02/003341
- Lead Sponsor
- SCDAS MEMORIAL MEDICAL AND RESEARCH CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
WOMEN UNDERGOING TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY WITH MENOPAUSAL SYMPTOMS WILL BE TREATED WITH EITHER ORAL TIBOLONE TABLETS 2.5 MG DAILY OR TRANSDERMAL OESTRADIOL GEL 2.5 GM AS HORMONE REPLACEMENT THERAPY.
Exclusion Criteria
1. THOSE WITH CONTRAINDICATIONS TO OESTROGEN LIKE SEVERE HYPERTENSION, UNCONTROLLED DIABETES; HEPATIC DISEASES; HISTORY OF VENOUS THROMBOEMBOLISM OR STROKE/ MYOCAEDIAL INFARCTION
2. CASES WITH HISTORY OF INTAKE OF OTHER FORMS OF HORMOBNE REPLACEMENT THERAPIES IN THE PRECEDING 3 MONTHS.
3. CASES ALREADY ON CALCIUM AND VITAMIN D3 SUPPLEMENTS.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CHANGE IN SERUM CALCIUM AND <br/ ><br>25-HYDROXY VITAMIN D3 LEVELS AFTER 6(SIX) MONTHS OF TREATMENT.Timepoint: 6 (SIX) MONTHS. <br/ ><br>
- Secondary Outcome Measures
Name Time Method ANY SIDE EFFECTS NOTED WITH TIBOLONE AND TRANSDERMAL OESTRADIOL GELTimepoint: WITHIN 6 MONTHS OF TREATMENT