Comparison of Two drugs in Urogenital Symptoms of Menopause

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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064620

Enrollment

100

Registered

2024-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: N952- Postmenopausal atrophic vaginitis

Interventions

Intervention1: tab Tibolone: tab Tibolone 2.5 mg daily for 3 months Intervention2: vaginal Estriol cream: Estriol vaginal cream 0.1% ,0.5 mg daily for 15 days in night and then 0.3 mg twice weekly

Eligibility

Inclusion criteria

Inclusion criteria: post menopausal female of less than 60 years with genitourinary syndrome

Exclusion criteria

Exclusion criteria: post menopausal female with Hypertension, Diabetes Mellites, heart disease, chronic liver and kidney disease , already on any hormone therapy for menopausal symptoms, history of thromboembolism, benign or malignant breast disease or with past history of breast carcinoma, family history of breast carcinoma, abnormal uterine bleeding or known genital premalignant or malignant lesion , Endometrial thickness more than 5 mm in transvaginal sonography , BMI more than 30, on any psychiatric treatment.

Design outcomes

Primary

Measure	Time frame
Improvement in urogenital symptoms after treatment on menopausal rating scaleTimepoint: AFTER 3 MONTHS TREATMNT	—

Secondary

Measure	Time frame
Vaginal Health Index & Vaginal Maturation IndexTimepoint: After 3 months of starting the treatment	—

Countries

India

Contacts

Public ContactVandana Verma

All India Institute of Medical Sciences, Raebareli

drvandana19@gmail.com07607903713

Outcome results

None listed

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