What this trial studies
This study is a randomized controlled sham applied study. Its aim is to evaluate the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women. In this study, demonstration of the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal pH measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual Analogue Scale (VAS) and ultrasonographic elastography
Conditions in scope
- Vaginal Atrophy
- Dyspareunia
- Laser
- Genitourinary Syndrome of Menopause (GSM)
Interventions
- Fotona Dynamis Er:YAG Laser System (Device) — The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 21 days. She receives 3 sessions, in total. Each session consists of application of PS03 handpiece intravaginal with spot size of 7 mm, fluence of 10…
- Sham (Device) — Er:YAG laser is applied with sham handpiece.
Who can join
Women only · Ages 18 Years and up
Inclusion criteria
- Postmenopausal women with vaginal atrophy symptoms
- Adult Female, 18 years of age or older
Exclusion criteria
- Patients with a history of previous vaginal operation,
- Patients with pelvic organ prolapse
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Istanbul | Istanbul University-Cerrahpaşa | Unknown | |
| Istanbul | Istanbul University-Cerrahpasa | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: N/A
- Start date: 2023-08-21
- Primary completion: 2024-01-01
- Last update posted: 2025-04-30
- First posted: 2023-08-21
Sponsor & contact
Lead sponsor: Istanbul University - Cerrahpasa (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Efficacy: Rate of improvement in vaginal atrophy (6 months)
Evaluation of the efficacy and safety of vaginal atrophy by using ultrasonographic Elastography - Efficacy:Rate of improvement in sexual function (6 months)
Evaluation of dyspareunia by Female Sexual Function Index - Efficacy: Rate of improvement in vaginal atrophy (6 months)
Evaluation of Maturation Index - Efficacy: Rate of improvement in vaginal atrophy (6 months)
Evaluation of Vaginal Health Index - Efficacy: Rate of improvement in pain (6 months)
Evaluated by Visual Analogue Scale
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06000202 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.