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Comparison of Vaginal Laser Therapy to Vaginal Estrogen Therapy

NCT02691936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-10-30

Study results available
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Summary

This is a multi-centered, randomized prospective single blinded clinical trial comparing CO2 fractionated vaginal laser therapy and vaginal estrogen cream therapy in the treatment of vulvovaginal atrophy/GSM.

Conditions

Interventions

DEVICE

CO2 fractionated vaginal laser

Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months

DRUG

Estrogens, Conjugated (USP)

Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks

Sponsors & Collaborators

  • Foundation for Female Health Awareness

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Marie F Paraiso, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02691936 on ClinicalTrials.gov