Status:
UNKNOWN
Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Syneron Candela
Conditions:
Dyspareunia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse in women who are ...
Detailed Description
This is a randomized trial to determine the comparative effectiveness of the CO2RE laser device relative to topical lidocaine in treating dyspareunia among breast cancer survivors. The large and growi...
Eligibility Criteria
Inclusion
- Subjects included must be female breast cancer survivors over the age of 18, sexually active (at least 4 episodes of sexual intercourse per month), and find intercourse painful. Subjects must also be English speaking and able to give informed consent.
Exclusion
- Subjects will be excluded if pregnant, has not had breast cancer, does not have painful intercourse secondary to treatment received for their breast cancer, is not English speaking, or lacks the ability to sign informed consent.
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03257670
Start Date
March 20 2018
End Date
June 1 2022
Last Update
September 28 2021
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267