Status:
COMPLETED
Vulvovaginal Atrophy Correction Using Neodymium Laser
Lead Sponsor:
MeLSyTech, Ltd
Conditions:
Postmenopausal Period
Vaginal Atrophy
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
The aim of this prospective study is characteristic of changes in the vaginal wall and vulva after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the v...
Detailed Description
The principle of participant distribution into groups is the main method of treatment of postmenopausal vaginal atrophy. Total up to 120 participants with postmenopausal atrophy will be involved in th...
Eligibility Criteria
Inclusion
- Age of over 50 years old, inclusive;
- Participants diagnosed with genitourinary menopausal syndrome with severe signs of vulvovaginal atrophy;
- Participants were examined according to the proposed protocol;
- Participants who signed informed consent and fully informed about the purpose of the study.
Exclusion
- Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- Porphyria;
- Active tuberculosis;
- Damage to the vaginal mucosa;
- Urinary tract infections in the acute stage;
- Genital herpes in the acute stage;
- Inflammatory diseases of the vulva and vagina in the acute stage;
- Oncological diseases of the female reproductive system, including history of oncological diseases;
- Precancerous diseases of the cervix, vagina and vulva;
- The use of drugs and other methods of treatment (including laser) that can affect the result, less than 1 month before the start of the study and during the study (Menopausal hormone therapy, the use of topical estriol; Kegel exercises, physiotherapy, the use of pelvic floor muscle trainers).
- Protocol non-compliance of laser exposure sessions;
- Voluntary refusal to participate in the study;
- Violation of recommendations for the management of the period after laser treatment;
- Adverse events that occurred during laser processing and research, and associated with them.
- The occurrence of adverse events or other symptoms that are contraindications to laser procedures, as well as the occurrence of cases described in the exclusion criteria.
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04735549
Start Date
September 1 2021
End Date
October 20 2023
Last Update
December 12 2024
Active Locations (1)
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1
Federal State Budget Institution "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov"
Moscow, Russia, 117997