Clinical Trial of the Safety and Efficacy of Medical Device "Laser Medical Device "Magic Gyno""
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline of Vaginal Health Index Score
研究概览
简要总结
The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose. To assess the condition of the vaginal walls and vulva before and after laser treatment, the following methods will be used: gynecology examination, vaginal health index, clinical blood test, vaginal flora examination, vaginal pH. International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), Female Sexual Function Index (FSFI) and The Short Form Health Survey (SF-36) will be used to collect feedback on changes in the participants life quality. Total up to 70 participants with pathology of pelvic organs will be involved in the study. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms, by 35 participants in each. The time intervals between tests will be the same for both groups. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the condition before treatment.
详细描述
The principle of participant distribution into groups is the character of vaginal walls and vulva pathology. Total up to 70 participants will be involved in the study. Participants will be divided into two groups: group with genitourinary symptoms and group with vaginal relaxation symptoms by 35 participants in each.
The types of examination of each group are the same and include:
General methods: demographic data determination, vital signs determination, gynecological examination, physical examination, clinical blood analysis with glucose determination, clinical urine test, vaginal smear for flora and oncocytology, pelvic ultrasound.
Special methods: vaginal smear for flora, vaginal pH determination, filling out the questionnaire (Female Sexual Function Index, International Consultation on Incontinence Questionnaire - Short Form, The Short Form Health Survey), Vaginal Health Index determination.
The treatment procedure of this study is the laser treatment of the vagina and vulva with a "Magic Gyno" laser with subsequent monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women from 18 years old in conditions caused by collagen deficiency in the treated area, women in premenopause and menopause;
- •Participants who signed informed consent and fully informed about the purpose of the study;
- •Following disorders:
- •Stress urinary incontinence,
- •Mixed urinary incontinence with a predominance of the stress component,
- •Genitourinary menopausal syndrome,
- •Dystrophic and atrophic processes in the genital area,
- •Scleroatrophic changes in the urogenital region,
- •Prolapse of the genitals I-II degree,
- •Vaginal relaxation syndrome,
- •Postpartum recovery,
- •Sexual dysfunctions,
- •Restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- •Preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
排除标准
- •Age up to 18 years;
- •Inability or unwillingness to give informed consent to participate in a trial or to fulfill the requirements of a clinical trial;
- •The presence of contraindications to the use of a medical device;
- •Pregnancy;
- •Bleeding disorders accompanied by a violation of blood clotting;
- •Use of anticoagulant medicines (post-infarction and post-stroke conditions);
- •Autoimmune diseases;
- •Emerging infection diseases of any etiology;
- •Damage to the skin (mucous membranes) in the area of laser treatment;
- •Oncological diseases, cancer alertness;
- •Decompensated diabetes;
- •Photosensitizing drug administration;
- •Decompensated somatic diseases;
- •Decompensated cardiovascular disease, and other decompensated common diseases;
- •Severe somatic diseases (heart failure, chronic renal failure, hepatitis, liver cirrhosis);
- •Severe autoimmune diseases (including hemorrhagic vasculitis);
- •Immunodeficiency (including HIV infection and AIDS);
- •Severe mental and neurological disorders;
- •Bedridden and immobile patients;
- •COVID 19;
- •Acute inflammatory diseases of the urogenital area;
- •Acute purulent processes of the urogenital region;
- •Bleeding of a natural nature (menstruation) and any other types of bleeding in the urogenital area;
- •Postoperative scars up to 6 months;
- •Lateral cysts of the vagina;
- •Growing uterine fibroid;
- •Fillers / suture in the area of laser exposure;
- •The presence of varicose veins of the urogenital region and dilated capillary plexuses of the mucosa.
研究组 & 干预措施
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Physical parameters determination (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Physical parameters determination (Diagnostic Test)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Laser treatment (Device)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Blood test (Diagnostic Test)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Clinical urine test (Diagnostic Test)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vaginal smear (Diagnostic Test)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Pelvic ultrasound (Diagnostic Test)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Female Sexual Function Index (Other)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: International Consultation on Incontinence Questionnaire - Short Form (Other)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: The Short Form Health Survey (Other)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vaginal Health Index (Diagnostic Test)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vital signs determination (Diagnostic Test)
Genitourinary disorder
Participants with:
- stress urinary incontinence,
- mixed urinary incontinence with a predominance of the stress component,
- genitourinary menopausal syndrome,
- dystrophic and atrophic processes in the genital area,
- scleroatrophic changes in the urogenital region.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: pH of vagina determination (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Laser treatment (Device)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Blood test (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Clinical urine test (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vaginal smear (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Pelvic ultrasound (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Female Sexual Function Index (Other)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: International Consultation on Incontinence Questionnaire - Short Form (Other)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: The Short Form Health Survey (Other)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vaginal Health Index (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: Vital signs determination (Diagnostic Test)
Relaxation of vagina
Participants with:
- prolapse of the genitals I-II degree,
- vaginal relaxation syndrome,
- postpartum recovery,
- sexual dysfunctions,
- restoration of tone, turgor and tissue density of the urogenital area (Intimate rejuvenation, correction of age-related changes),
- preoperative preparation for genital prolapse surgery and postoperative rehabilitation.
Laser treatment of the vagina, vulva, and paraurethral region with "Magic Gyno" laser. In total, three procedures will be performed with an interval of 4 weeks.
During the procedure, the following sequence of actions will be performed:
- st Stage - vaginal processing with a conical mirror handpiece,
- nd Stage - vaginal processing with a corner mirror handpiece,
- d Stage - external vulva and paraurethral region processing with a switched beam diameter handpiece.
干预措施: pH of vagina determination (Diagnostic Test)
结局指标
主要结局
Mean Change from Baseline of Vaginal Health Index Score
时间窗: 1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit)
Vaginal Health Index will be investigated by clinical examination for vagina: A. Vaginal elasticity (Characteristic=Points: None=1, Poor=2, Fair=3, Good=4, Excellent=5), B. Vaginal secretions (None=1; Sсant, thin yellow=2; Superficial, thin white=3; Moderate, thin white=4; Normal (white)=5), C. Epithelial mucous membrane (Petechiae noted before contact=1, Bleeding with light contact=2, Bleeds with scraping=3, Not friable thin epithelium=4, Normal=5), D. Vaginal hydration (None, surface inflamed=1, None, surface nod inflamed=2, Minimal=3, Moderate=4, Normal=5), E. pH will be investigated by test-lines paper (≥6.1=1, 5.6-6.0=2, 5.1-5.5=3, 4.7-5.0=4, ≤4.6=5). Score=A+B+C+D+E
次要结局
- Mean Change from Baseline of Total Score on International Consultation on Incontinence Questionnaire - Short Form(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Desire" Score on the Female Sexual Function Index Questionnaire(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Arousal" Score on the Female Sexual Function Index Questionnaire(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Orgasm" Score on the Female Sexual Function Index Questionnaire(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Pain" Score on the Female Sexual Function Index Questionnaire(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Lubrication" Score on the Female Sexual Function Index Questionnaire(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Satisfaction" Score on the Female Sexual Function Index Questionnaire(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Physical Health Component Score" on The Short Form Health Survey(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of pH of vagina(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of "Mental Health Component Score" on The Short Form Health Survey(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))
- Mean Change from Baseline of Lactobacilli quantity(1st visit (initial screening); 2nd visit (before the first treatment, no latter 2 months after 1st visit), 4th visit (before the last treatment, 8-12 weeks after 2nd visit); 5th visit (90 days after the last treatment - 4th visit))