NCT05335317 Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser
| NCT ID | NCT05335317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MeLSyTech, Ltd |
| Condition | Postmenopausal Period |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-04-18 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-04-18 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Liya Z Sirotina
PRINCIPAL INVESTIGATOR
Privolzhsky Research Medical University
Frequently Asked Questions
Who can join the NCT05335317 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 75 Years, studying Postmenopausal Period. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05335317 currently recruiting?
Yes, NCT05335317 is actively recruiting participants. Contact the research team at shatilova@melsytech.com for enrollment information.
Where is the NCT05335317 trial being conducted?
This trial is being conducted at Nizhny Novgorod, Russia.
Who is sponsoring the NCT05335317 clinical trial?
NCT05335317 is sponsored by MeLSyTech, Ltd. The principal investigator is Liya Z Sirotina at Privolzhsky Research Medical University. The trial plans to enroll 120 participants.