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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.

ORAL TIBOLONE VERSUS TRANSDERMAL OESTRADIOL GEL- EFFECTS ON SERUM CALCIUM AND 25 HYDROXY VITAMIN D LEVELS AFTER SURGICAL MENOPAUSE.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003341
Enrollment
60
Registered
2013-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- SURGICALLY MENOPAUSAL WOMEN WITH MENOPAUSAL SYMPTOMS

Interventions

Intervention1: ORAL TIBOLONE 2.5 MG DAILY VERSUS TRANSDERMAL OESTRADIOL GEL 2.5 GM DAILY: TIBOLONE- 1 TABLET DAILY FOR 6 MONTHS TRANSDERMAL OESTRADIOL GEL 2.5 GM APPLIED TRANSDERMALLY DAILY FOR 6 MONT

Sponsors

SCDAS MEMORIAL MEDICAL AND RESEARCH CENTER
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
CHANGE IN SERUM CALCIUM AND 25-HYDROXY VITAMIN D3 LEVELS AFTER 6(SIX) MONTHS OF TREATMENT.Timepoint: 6 (SIX) MONTHS.—

Secondary

MeasureTime frame
ANY SIDE EFFECTS NOTED WITH TIBOLONE AND TRANSDERMAL OESTRADIOL GELTimepoint: WITHIN 6 MONTHS OF TREATMENT—

Countries

India

Contacts

Public ContactDRSUDHINDRA MOHAN BHATTACHARYA

S.C.DAS MEMORIAL MEDICAL AND RESEARCH CENTER

drsudhindra54@gmail.com24303400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026