Effects of Erbium-Yag Laser in Women With Genitourinary Syndrome of Menopause Undergoing Estrogen Therapy

Launched by UNIVERSITY OF NOVE DE JULHO · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special laser treatment called Erbium:YAG laser on postmenopausal women who have Genitourinary Syndrome of Menopause (GSM). GSM can cause issues like vaginal dryness and discomfort due to low estrogen levels. The researchers want to see if using this laser, along with a low-dose estrogen cream, can help improve symptoms for women who are experiencing moderate symptoms of GSM.

To participate in the study, women aged 45 to 70 who haven’t had their period for at least two years and have certain symptoms related to GSM may be eligible. Participants will receive either the laser treatment or a placebo (a non-active version) after using the estrogen cream for two weeks. They will attend several follow-up appointments to measure changes in their symptoms and overall vaginal health. This study aims to find out if the laser treatment can give better relief than just using estrogen cream alone.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with amenorrhea present for at least 24 months.
• • Women with amenorrhea for more than 12 months and FSH levels \> 30 mUI/MI and estradiol \< 30 mUI/MI, collected specifically for this research.
• • Age between 45 to 70 years.
• • Vaginal pH measurement \>= 5.
• • Present at least one of these moderate symptoms of GSM (dyspareunia, dryness, burning, and persistent leukorrhea). Each of these will be assessed separately by the patient, according to the Visual Analog Scale (VAS) criteria, from 0 (absence of symptoms) to 10 (very severe symptoms). Moderate symptoms will be considered as values equal to or greater than 4.
• • Not users of hormonal replacement therapy (oral or systemic) in the last 6 months.
• • Not users of vaginal moisturizers in the last 30 days.
• Exclusion Criteria:
• • Vaginal treatments using energy in the last 6 months.
• • Patients with altered Pap smear results with cellular changes such as ASCUS, LSIL, or HSIL in the last 6 months.
• • Corticotherapy in the last 90 days.
• • BMI \>= 35 kg/m².
• • Abnormal uterine bleeding in the last 30 days.
• • History of vaginal surgeries in the last 180 days or uterine prolapse Grade II or higher.
• • Patients with a prior diagnosis of malignant neoplasms of any nature or currently undergoing treatment; prior vaginal radiotherapy, severe liver and kidney diseases already diagnosed by previous tests, autoimmune diseases, and severe psychiatric disorders.