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Comparison of the Efficacy of Vaginal Radiofrequency and Vaginal Estrogen Therapy in the Treatment of Genitourinary Syndrome of Menopause

Comparison of Vaginal Radiofrequency and Vaginal Estrogen Treatments in Improving Symptoms of Genitourinary Syndrome in Menopausal Women

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160521027998N12
Enrollment
60
Registered
2025-02-24
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Urogenital syndrome. Postmenopausal atrophic vaginitis

Interventions

Intervention 1: Intervention group 1: Participants in the RF group will undergo at least three vaginal treatments with a 30-day interval. Post-treatment care includes the application of a 5% dexpanthe

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 45 and 65 years Diagnosis of Genitourinary Syndrome of Menopause (GSM) based on clinical symptoms No use of systemic or local estrogen hormone therapy in the past 6 months Use of systemic or local estrogen hormone therapy in the

Exclusion criteria

Exclusion criteria: History of sensitivity or allergy to the materials used in the treatment Presence of active inflammatory or infectious diseases in the pelvic region History of cancers related to the reproductive or urinary systems Pregnancy or breastfeeding Use of other hormonal or non-hormonal treatments during the study Blood coagulation disorders or use of anticoagulant medications Concurrent participation in other clinical trials Unwillingness to comply with the study protocols

Design outcomes

Primary

MeasureTime frame
The severity of genitourinary syndrome symptoms in postmenopausal women based on a specified questionnaire. Timepoint: Before starting the intervention, 3 and 6 months after prescription. Method of measurement: Women's Sexual Function Questionnaire, Urinary and Genital Distress Inventory (UDI-6).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Hajihashemi

Esfahan University of Medical Sciences

m_hajihashemy@med.mui.ac.ir+98 31 3776 6578

Outcome results

None listed

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