Active — Not RecruitingNot Applicable

LASER and Radiofrequency and Genitourinary Syndrome of Menopause

Brazil195 participantsStarted 2019-08-05

Plain-language summary

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic strogen to treat symptoms of vulvovaginal atrophy of post menopause.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Women between 2 and 5 years after menopause, without hormone therapy for at least 2 years
✓. 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 of vulvovaginal atrophy:

Exclusion criteria

✕. Active genital infection, active infection of HPV (human papillomavirus) or Herpes, users of medications with estrogenic effect (digoxin, tamoxifen 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 postmenopausal genitourinary syndrome with intravaginal LASER, Microablative Radiofrequency, and topic estriol

Timeframe: The evaluation will be done 180 days after treatment

Satisfaction of postmenopausal women with genitourinary syndrome with the treatment by intravaginal LASER, Micro ablative Radiofrequency, and topic estriol

Timeframe: The evaluation will be done 180 days after treatment

Trial details

NCT IDNCT04045379

SponsorFederal University of São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08

View on ClinicalTrials.gov More Postmenopausal Atrophic Vaginitis trials