Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT03372720
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Fractional CO2 Laser Therapy for Survivors of Gynecologic Malignancies
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-02051 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |