Use of Fractional CO2 Laser Versus Erbium:YAG Laser for the Treatment of GSM in Patients Using Aromatase Inhibitors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

To study the efficacy and safety of intravaginal CO2 laser versus intravaginal Er:YAG laser and sham application in alleviating genitourinary symptoms in patients receiving an aromatase inhibitor as adjuvant treatment of breast cancer

Eligibility criteria

Qualifiers

a history of breast cancer

premenopausal at diagnosis of breast cancer

using AI as an adjuvant treatment

moderate to severe symptoms of GSM (VAS ≥ 4/10)

Disqualifiers

Not willing to abstain from vaginal intercourse for 1 week following laser therapy

Use of non-hormonal vaginal preparations within the last 6 weeks before inclusion

Use of hormonal therapy within 6 months prior to inclusion (systemic or local)

Acute urinary or genital tract infections

Trial design

Treatments tested in this trial

  • intravaginal laser

Treatment groups

162 Participants
are divided into 3 treatment groups