Effect of oral menopausal hormone therapy on vaginal microbiome in patients with hot flushes and vaginal symptoms

The effect of hormone therapy on vaginal microbiota in women with genitourinary syndrome of menopause: a double-blind, randomized placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241216001

Enrollment

Registered

2024-12-16

Start date

2024-12-23

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

Genitourinary symdrome of menopause Vasomotor symptoms Menopausal hormone therapy Vaginal microbiome Genitourinary syndrome of menopause Vasomotor symptoms

Interventions

Estradiol 1 mg with dydrogesterone 5 mg taken one tablet once daily before bedtime for 12 weeks ,Placebo taken one tablet once daily before bedtime for 12 weeks

Experimental Drug,Placebo Comparator No treatment

Estradiol/dydrogesterone,Placebo

Eligibility

Sex/Gender

Female

Age

40 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Menopausal women aged 40-60 years old with amenorrhea more than 12 months 2. FSH > 40 IU/L 3. Presence of GSM (dryness, itching/ irritation, soreness, dyspareunia) and vasomotor symptoms 4. Agree to participate in study

Exclusion criteria

Exclusion criteria: 1. Treated GSM with local vaginal medication including hormones and non-hormonal treatment within 3 months 2. Pelvic organ prolapse stage 3 or 4, Condyloma accuminata, Vaginal tumors 3. BMI > 35 kg/m2 4. Spermicide use within 3 months 5. Vaginal surgery within 3 months 6. Vaginal infection within 1 month 7. History of pelvic radiotherapy 8. Chronic liver or renal diseases 9. History of malignancy 10. History of VTE

Design outcomes

Primary

Measure	Time frame
Vaginal microbiota 12 weeks 16SrDNA high-throughput sequencing	—

Secondary

Measure	Time frame
Most bothersome symptoms 6 and 12 weeks Most bothersome symptoms ,Vaginal Maturation Value 6 and 12 weeks Vaginal cytology,Vaginal Health Index 6 and 12 weeks Vaginal cytology	—

Countries

Thailand

Contacts

Public ContactKrasean Panyakhamlerd

Faculty of Medicine, Chulalongkorn University

krasean.p@chula.ac.th022564824

Outcome results

None listed

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