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Search / Trial NCT06691178

Vaginal Changes After CO2 Laser

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Nov 13, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called CO2 laser therapy for women experiencing genitourinary syndrome of menopause (GSM). GSM is a condition that occurs when estrogen levels drop during menopause, leading to symptoms like vaginal dryness, burning, painful intercourse, and urinary issues. The trial aims to see how effective the laser treatment is by comparing women who receive the therapy with those who do not receive any treatment (a sham group). Researchers will use a special imaging technology to observe changes in the vaginal tissue and will also ask participants to complete questionnaires about their symptoms.

To be eligible for this trial, participants must be women aged 18 and older who are postmenopausal and interested in laser therapy for GSM. They should not be on hormone replacement therapy or have certain medical histories, such as pelvic radiation or recurrent urinary tract infections. If you join the study, you will have the opportunity to receive laser treatment and help researchers learn more about non-hormonal options for managing GSM.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Birth sex: female
  • 2. Desire for vaginal laser therapy for GSM
  • 3. Age \>=18 years old
  • 4. Willingness to forego other treatments for GSM within the study period
  • 5. Diagnosed as postmenopausal (either by surgical removal of ovaries or natural progression defined as no periods in 1 year)
  • Exclusion Criteria:
  • 1. History of pelvic radiation
  • 2. On hormone replacement therapy in the prior 3 months
  • 3. Not able or willing to follow study instructions
  • 4. Current diagnosis of recurrent UTIs

About University Of California, Irvine

The University of California, Irvine (UCI) is a leading research institution renowned for its commitment to advancing health and medical knowledge through innovative clinical trials. With a robust infrastructure for clinical research, UCI fosters interdisciplinary collaboration among its esteemed faculty and researchers, aiming to translate scientific discoveries into effective therapeutic solutions. The university prioritizes ethical standards and participant safety while addressing critical healthcare challenges across various fields, including cancer, neurology, and public health. UCI's dedication to excellence in research and education positions it as a pivotal contributor to the advancement of clinical science and patient care.

Locations

Irvine, California, United States

Patients applied

0 patients applied

Trial Officials

Felicia Lane, MD

Principal Investigator

University of California, Irvine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported