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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20231012006

Enrollment

Registered

2023-10-12

Start date

2024-01-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

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

Interventions

estradiol hemihydrate 10 mcg tablet,estradiol hemihydrate 10 mcg gel

Active Comparator Drug,Active Comparator Drug

tablet,gel

Eligibility

Sex/Gender

Female

Age

45 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
VMV 3 months VMV score	—

Secondary

Measure	Time frame
most bothersome symptoms 3, 6 months questionaire,vaginal pH 3 and 6 month pH,vaginal health index 3 and 6 month VHI,FSFI 3 and 6 months questionnaire,endometrial thickness 3 and 6 months ET,Estradiol 3 and 6 months blood measurement ,ease of administration 3 and 6 months questionnaire,comfort of administration 3 and 6 months questionnaire,overall acceptability 3 and 6 months questionnaire	—

Countries

Thailand

Contacts

Public Contactkanchanok taemamu

Faculty of medicine, siriraj hospital

t.kanchanok3@gmail.com0869081114

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026