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

NCT04081805 | Active Not Recruiting DMC

• 1 other identifier: CEP0431/2018 arm 2
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Atrophy; Vulva; Atrophy; Breast Cancer

Keywords

LASER; Radiofrequency; Vulvovaginal atrophy; breast cancer; treatment

Outcome Measures

Primary Outcomes (2)

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

  Will be applied a Visual Analogic Scale (0-10) to access the improvement of genitourinary signs and symptoms, the results of the three groups will be compared

  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

  Will be applied a LIKERT Satisfaction Scale (1-5) to access the satisfaction with the treatment, the results of the three groups will be compared

  The evaluation will be done 90 days after treatment

Secondary Outcomes (8)

• Evaluation of Microbiota before and after the use of intravaginal LASER, Micro Ablative radiofrequency or topic promestriene

  The evaluation will occur pre-treatment 30, 90 , 180 and 360 days after treatment]

• Evaluation of vaginal pH before and after the use of intravaginal LASER, Micro ablative radiofrequency or topic promestriene

  The evaluation will occur pre-treatment and 30, 90, 180 and 360 days after treatment

• Histologic evaluation of vagina and vulva before and after the use of intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

  The evaluation will occur pre-treatment and 30 and 180 days after treatment

• Evaluation of impact in Quality of life after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

  The evaluation will occur pre-treatment and 30 and 180 and 360 days after treatment]

• Evaluation of impact in Sexual function after treatment with intravaginal and vulvar LASER, Micro Ablative radiofrequency or topic promestriene.

  The evaluation will occur pre-treatment and 30 180 and 360 days after treatment

Study Arms (3)

LASER

ACTIVE COMPARATOR

The patients will receive 3 consecutive applications of intravaginal and vulvar CO2 LASER, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days

Procedure: LASER

Micro Ablative Radiofrequency

ACTIVE COMPARATOR

The patients will receive 3 consecutive applications of intravaginal and vulvar MIcroablative radiofrequency, according to the manufacturer protocol for vaginal atrophy. The applications will be separated by the interval of 30 days

Procedure: Micro Ablative Radiofrequency

Promestriene

ACTIVE COMPARATOR

The patient will use intravaginal promestriene, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the promestriene tube to verify the correct use.

Drug: Promestriene

Interventions

LASER PROCEDURE

The patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use.vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured.

Also known as: Fractional Co2 (carbon dioxide)Laser, MonaLisa Touch® treatment, SmartXide Touch V²LR® Deka

LASER

Micro Ablative Radiofrequency PROCEDURE

Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured

Also known as: FRAAX, Linly™ Loktal Medical Electronics

Micro Ablative Radiofrequency

Promestriene DRUG

The patient will perform self application of this vaginal promestriene daily for 2 weeks and after that the applications will occur twice a week.

Also known as: Vaginal Promestriene

Promestriene

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• presence of genitourinary or rectovaginal fistulas

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, 0-4023- 062, Brazil

Location

Related Publications (2)

• Cantarelli GC, Bianchi-Ferraro AMHM, Dedonatto C, Fernandes MFR, Vanzin RB, Dardes RCM, Logullo AF, de Almeida JS, Facina G, de Jarmy-Di Bella ZIK, Sartori MGF, Patriarca MT; LARF-Study Group. Clinical and histomorphometric evaluation of the vagina following treatment with CO2 laser, radiofrequency, and promestriene for genitourinary syndrome of menopause in breast cancer survivors on adjuvant therapy. Maturitas. 2025 Jan;191:108155. doi: 10.1016/j.maturitas.2024.108155. Epub 2024 Nov 14.

  PMID: 39566128 DERIVED

• Fernandes MFR, Bianchi-Ferraro AMHM, Sartori MGF, Jarmy Di Bella ZIK, Cantarelli GC, Dedonatto C, Vanzin RB, Dardes RCM, Logullo AF, Patriarca MT; LARF Study Group. CO 2 laser, radiofrequency, and promestriene in the treatment of genitourinary syndrome of menopause in breast cancer survivors: a histomorphometric evaluation of the vulvar vestibule. Menopause. 2023 Dec 1;30(12):1213-1220. doi: 10.1097/GME.0000000000002274. Epub 2023 Nov 14.

  PMID: 37963315 DERIVED

MeSH Terms

Conditions

Atrophy; Breast Neoplasms

Interventions

Lasers; Lasers, Gas; promestriene

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Zsuzsanna IK Jarmy-di Bella, PhD

  Professor

  STUDY CHAIR

• Marair GF Sartori, PhD

  Professor and Head of Gynecology Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the outcomes assessor will not have access to the treatment that was used in each patient. the investigator will not have acess to the treatment that was used in each group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigador

Model Details: The patient will be randomized in block to receive one of the three intravaginal therapies: LASER, Radiofrequency and promestriene

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: September 9, 2019
• Study Start: September 30, 2019
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

BR (1)