Status:
ACTIVE_NOT_RECRUITING
LASER and Radiofrequency and Genitourinary Syndrome of Menopause
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Postmenopausal Atrophic Vaginitis
Postmenopausal Symptoms
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief 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.
Detailed Description
Post menopause women 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 intravaginal therapi...
Eligibility Criteria
Inclusion
- 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:
- 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.
- The Exclusion criteria will be:
- 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.
Exclusion
Key Trial Info
Start Date :
August 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04045379
Start Date
August 5 2019
End Date
August 1 2025
Last Update
April 22 2025
Active Locations (1)
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1
Federal University of Sao Paulo - Unifesp
São Paulo, São Paulo, Brazil, 0-4023- 062