Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.
Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Female Sexual Dysfunction.
1 other identifier
interventional
120
1 country
1
Brief Summary
The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with sexual dysfunction. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2021
CompletedStudy Start
First participant enrolled
October 4, 2021
CompletedFirst Posted
Study publicly available on registry
October 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedApril 20, 2022
April 1, 2022
1.2 years
October 4, 2021
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Vaginal health index
Change in total and specific vaginal health index scores
From treatment up to 12 months post treatment
Secondary Outcomes (2)
Female sexual function index
From treatment up to 12 months post treatment
Sexual intercourse
From treatment up to 12 months post treatment
Study Arms (2)
Laser treatment
ACTIVE COMPARATORCarbon dioxide laser treatment
Sham treatment
SHAM COMPARATORSham laser treatment
Interventions
Eligibility Criteria
You may qualify if:
- Negative urine analysis.
- Normal Pap smear test from the recent 3 years.
- No previous gynecological laser treatments.
- Able and willing to comply with the treatment/follow-up schedule and requirements.
You may not qualify if:
- Active genital infection.
- Subject presenting abnormal Pap result from the last three years.
- Recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year).
- Transvaginal mesh implant.
- Serious systemic disease or any chronic condition that could interfere with study compliance.
- Any vaginal bleeding of unknown reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam health care campus
Haifa, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Lauterbach, MD
Rambam healthcare campus
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 4, 2021
First Posted
October 28, 2021
Study Start
October 4, 2021
Primary Completion
December 31, 2022
Study Completion
November 30, 2023
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share