Study: NCT05335317

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Laser Treatment
Description: Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 ns, the pause between pulses is 30 us. The energy of one pulse is about 1 mJ.~General laser radiation parameters for 1st and 2nd stages are: beam with diameter of 4 millimeters (mm) scans treatment area by 4 circles with step of 2 mm (50% overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm (total handpiece length of 10 centimeter (cm), 20 treatment points along vagina), from 1 to 5 repetitions of total vagina treatment. General laser radiation parameters for 3d stage are: beam diameter of 6 mm, average power of 15-30 W, duration of ns-pulses packet of 100 milliseconds (ms), pause between packets of 50 ms, treatment duration up to 65 s, treatment in permanent motion with speed of 10-50 mm/s.~The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Topical hormone estriol
Description: Estriol suppository ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Active ingredient of 0.5 milligram in 1 suppository. Daily dose will be 1 suppository.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Сlinical blood analysis
Description: Taking blood from a vein for Clinical blood analysis (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Сlinical blood analysis
Description: Taking blood from a vein for Clinical blood analysis (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Сlinical urine test
Description: Urine sampling for Clinical urine test (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Сlinical urine test
Description: Urine sampling for Clinical urine test (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Vaginal smear
Description: Vaginal smear for flora investigation (to include the participant in the study), immunocytochemical examination and cytology (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Vaginal smear
Description: Vaginal smear for flora investigation (to include the participant in the study), immunocytochemical examination and cytology (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Cervical oncocytology test.
Description: Cervical smear for oncocytology test (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Cervical oncocytology test.
Description: Cervical smear for oncocytology test (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Extended colposcopy
Description: Extended colposcopy is performed under a microscope using a Lugol to determine external changes in the epithelium in order to determine atrophy and pathologies of the cervix and vaginal vault (dysplasia, erosion, cancer, etc.) (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Extended colposcopy
Description: Extended colposcopy is performed under a microscope using a Lugol to determine external changes in the epithelium in order to determine atrophy and pathologies of the cervix and vaginal vault (dysplasia, erosion, cancer, etc.) (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Pelvic ultrasound
Description: Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Pelvic ultrasound
Description: Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: King's Health Questionnaire
Description: The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: King's Health Questionnaire
Description: The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Vaginal Health Index
Description: Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. pH (potential of hydrogen) will be investigated by test-lines paper (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Vaginal Health Index
Description: Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. pH (potential of hydrogen) will be investigated by test-lines paper (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Vaginal Health Index
Description: Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. pH (potential of hydrogen) will be investigated by test-lines paper (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Ultrasound investigation
Description: Ultrasound investigation with General Electric Voluson E8 Expert for assessing blood vessels (Doppler sonography) and vaginal wall thickness measurement (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Ultrasound investigation
Description: Ultrasound investigation with General Electric Voluson E8 Expert for assessing blood vessels (Doppler sonography) and vaginal wall thickness measurement (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Perineometry
Description: Pressure force of vaginal walls measurement with IEASE device (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Perineometry
Description: Pressure force of vaginal walls measurement with IEASE device (to evaluate procedure efficiency).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Optical coherence tomography
Description: Optical non-invasive method of investigation vaginal mucus morphological and functional condition.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Optical coherence tomography
Description: Optical non-invasive method of investigation vaginal mucus morphological and functional condition.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Biopsy
Description: Biopsy of the vaginal wall to assess the condition of the vaginal wall and compare the obtained data with the data of optical coherence tomography.

Intervention type: DIAGNOSTIC_TEST
Group type: OTHER
Intervention: Biopsy
Description: Biopsy of the vaginal wall to assess the condition of the vaginal wall and compare the obtained data with the data of optical coherence tomography.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Femoflor screen
Description: Femoflor screen for the study of vaginal microbiocenosis, specifically for the detection of the pathogens, opportunistic flora and normal flora and their qualitative and quantitative evaluation (to include the participant in the study).

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Femoflor screen
Description: Femoflor screen for the study of vaginal microbiocenosis, specifically for the detection of the pathogens, opportunistic flora and normal flora and their qualitative and quantitative evaluation (to include the participant in the study).