Active — Not RecruitingNot Applicable

LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)

Brazil195 participantsStarted 2019-09-30

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexFEMALE

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Inclusion criteria

✓. 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:
✓. 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 criteria

✕. 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

What they're measuring

Clinical Improvement of signs and symptoms of vulvovaginal atrophy with intravaginal LASER, Micro Ablative Radiofrequency, and topic promestriene

Timeframe: The evaluation will be done 90 days after treatment]

Satisfaction with treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic promestriene for women treated for breast cancer, with genitourinary atrophy syndrome

Timeframe: The evaluation will be done 90 days after treatment

Trial details

NCT IDNCT04081805

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

View on ClinicalTrials.gov More Vaginal Atrophy trials