Effectiveness of 12.5 microgram versus 25 microgram 17beta-estradiol estrogen vaginal gel in postmenopausal vaginal atrophy women: A 3-month randomized non-inferior trial

Phase 1

Completed

• Conditions: Postmenopausal vaginal atrophy; vaginal atrophy

• Registration Number: TCTR20220510004
• Lead Sponsor: Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-10
• Study Completion: 2023-02-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1.Postmenopausal women aged 45 years older
2.Who were amenorrhea for 12 months or who had undergone bilateral oophorectomy since 6 weeks or more
3.Vaginal symptoms related to postmenopausal status (vaginal dryness, vaginal or vulvar irritation, vaginal soreness, vaginal discharge, and/or dyspareunia).
4.Endometrial thickness no more than 5 mm as measured by transvaginal ultrasonography among women with uterus
5.Normal cervical cytology within 3 years
6.Informed consent

Exclusion Criteria

1.Known or suspected history of breast cancer
2.Abnormal uterine bleeding with unknown cause
3.Thromboembolism
4.Hypersensitivity to the study medication or ingredient
5.Previous hormone use within 90 days
6.Genital tract infection
7.Cardiovascular disease
8.Liver disease or gallbladder disease
9.Denied to participate in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified