Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT03372720
Brief Summary:
This randomized pilot trial studies how well fractional carbon dioxide (CO2) laser therapy works in minimizing genitourinary syndrome of menopause (GSM) in gynecological cancer survivors. Fractional CO2 laser therapy may reduce symptoms of GSM in survivors of gynecologic cancers.
Detailed Description:
PRIMARY OBJECTIVES:
I. To conduct a pilot trial to estimate the proportion of gynecologic cancer patients with vaginal dryness or dyspareunia, who will have an improvement in their symptoms with vaginal laser therapy compared to sham treatment based on the Vaginal Assessment Scale (VAS).
SECONDARY OBJECTIVES:
I. To evaluate toxicity associated with vaginal laser therapy in this population.
II. To determine how many women with the defined patient eligibility will complete all treatments.
III. To determine the feasibility of the crossover design for potential use in a phase III trial.
IV. To determine improvement in objective findings of vaginal atrophy with vaginal laser therapy versus sham treatment.
V. To determine improvement in sexual function as measured by Female Sexual Function Index (FSFI), Female Sexual Distress Scale-Revised (FSDS), and scales for sexual satisfaction and behavior with vaginal laser therapy versus sham treatment.
VI. To determine improvement in urinary symptoms of urogenital atrophy with vaginal laser therapy versus sham treatment using the Urogenital Distress Inventory (UDI).
VII. To demonstrate satisfaction with vaginal fractional CO2 laser therapy.
OUTLINE: Patients are randomized in to 1 of 2 arms.
ARM I: Patients undergo fractional CO2 laser therapy at 3 time points 30 days apart.
ARM II: Patients undergo sham laser therapy at 3 time points 30 days apart. Patients may then crossover to Arm I.
After completion of study, patients are followed up at 1 month.
Study:
NCT03372720
Study Brief:
Protocol Section:
NCT03372720