Treatment of vaginal atrophy using a low-intensity laser

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effects of low-intensity neodymium laser treatment on the vaginal wall in postmenopausal women experiencing vaginal atrophy. Participants will be divided into three groups: one receiving laser treatment, another receiving topical hormone therapy, and a control group receiving no treatment. Various assessments, including vaginal health indices and imaging techniques, will be conducted before and after treatment to measure changes in vaginal health. The study will involve up to 120 participants, with follow-up visits scheduled after the treatment procedures.

Why it matters

Who can join: the full rules

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.

Where it's running

• State-Funded Healthcare Institution of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N.A. Semashko"
  Nizhny Novgorod, Russia Recruiting

Study contacts

• Principal investigator: Liya Z Sirotina — Privolzhsky Research Medical University
• Study coordinator: Ksenia V Shatilova, Ph.D.
• Email: shatilova@melsytech.com
• Phone: +79262792700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.