Status:
RECRUITING
Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser
Lead Sponsor:
MeLSyTech, Ltd
Conditions:
Postmenopausal Period
Vaginal Atrophy
Eligibility:
FEMALE
40-75 years
Phase:
NA
Brief Summary
The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and aft...
Detailed Description
The principle of participant distribution into groups is the main method of treatment of postmenopausal vaginal atrophy. Total up to 100 participants with and 20 participants without postmenopausal at...
Eligibility Criteria
Inclusion
- Age of 40-75 years, inclusive;
- Vaginal atrophy or 1st grade vaginal prolapse with atrophy, or lack of vaginal atrophy in case of control group 2;
- All participants have informed consent to conduct a course of procedures according to protocol, carry out follow-up visits, and conduct studies.
Exclusion
- Age of under 40 and over 75 years old;
- History of oncological diseases;
- Active tuberculosis;
- Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage;
- Urinary tract infections;
- Damage to the vaginal mucosa;
- Pregnancy;
- Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);
- Porphyria;
- Cardiac deficiency of 2-3 degrees;
- Chronic renal disease;
- Participants with greater than 1st grade vaginal prolapse;
- Women after childbirth up to 8 weeks;
- Participants who, according to the doctor, are not able to complete the study;
- 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 appearance of contraindications listed in the Exclusion criteria.
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05335317
Start Date
April 18 2022
End Date
December 1 2025
Last Update
December 12 2024
Active Locations (1)
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1
State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko"
Nizhny Novgorod, Russia, 603126