Randomized cross-over study investigating the effectiveness of Estradiol Hemihydrate 10 mcg vaginal tablet versus vaginal gel in postmenopausal women with vaginal atrophy

Phase 3

• Conditions: postmenopausal women with vaginal atrophy require vaginal form of estradiol to improve symptoms; menopause, GSM, VMI, estradiol

• Registration Number: TCTR20231012006
• Lead Sponsor: Research fund from Faculty of Medicine Siriraj Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-12
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-02

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1. age > 45 years
2. menopause > 12 months
3.bothersome symptoms of vagina at least 2 symptoms
4. TVS show ET < 5 mm
5. PAP smear normal within 3 years
6. willing to participate

Exclusion Criteria

1. CA brest
2. AUB
3. VTE
4. allergy to estrofem or KY gel
5. previous estrogen used within 3 months
6. vaginitis
7. heart disease
8. liver disease
9. deny to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VMI 3 months VMI score

Secondary Outcome Measures

Name	Time	Method
most bothersome symptoms 3, 6 months questionaire