Status:
ACTIVE_NOT_RECRUITING
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Vaginal Atrophy
Vulva; Atrophy
Eligibility:
FEMALE
30-75 years
Phase:
NA
Brief Summary
This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.
Detailed Description
Women treated for breast cancer with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study. The patients will be randomized to receive one of the three intravagi...
Eligibility Criteria
Inclusion
- Women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy
- To present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of vulvovaginal atrophy:
- Burning
- Discomfort
- Dryness
- Cracks
- Pruritus
- Lack of vaginal lubrication
- Penetration dyspareunia that began at the menopausal or postmenopausal transition
- Decreased vaginal epithelium turgor and trophism
- Deletion of mucous and skin folds.
- Absence of vaginal surgical procedure in the last year
- Genital prolapse stage no greater than stage II of Pelvic Organs Prolapse Quantitation (POP-Q) with Ba, Bp or C points less than or equal to 0
Exclusion
- Active genital infection
- Active infection of HPV (human papillomavirus) or Herpes
- users of medications with estrogenic effect (digoxin and other chemicals)
- Postmenopausal genital bleeding
- uncontrolled diabetes
- use of multivitamins with zinc
- use of copper or hormonal IUDs (intrauterine device) at the time of inclusion
- presence of genitourinary or rectovaginal fistulas
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04081805
Start Date
September 30 2019
End Date
September 1 2025
Last Update
April 24 2025
Active Locations (1)
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1
Federal University of Sao Paulo - Unifesp
São Paulo, São Paulo, Brazil, 0-4023- 062