Efficacy and safety of Woman ISDIN® Vaginal Moisturizer in the alleviation of vaginal atrophy symptoms Skin and Connective Tissue Diseases
Conditions
Interventions
The treatment period will last 12 weeks for each patient, during which time they will use the investigational product as directed in the instructions. Therefore, it is expected to carry out 3 visits p
1 baseline selection visit where the study products are provided, 2 follow-up visits every 1 and 3 months after baseline visit.
Sponsors
Isdin (Spain)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Woman aged 18-75 years old. 2. Postmenopausal woman (=12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels >40 IU/L), both natural post menopause or iatrogenic conditions. 3. At least one of the following symptoms of vaginal atrophy, assessed as moderate to severe: 3.1. Vaginal dryness, 3.2. Vulvovaginal irritation/itching experienced at least weekly within the past 30 days, 3.3. Vaginal pain associated with sexual activity at least once monthly. 4. Vulvovaginal atrophy with VHI 5.0 6. Women with active sex life.
Exclusion criteria
Exclusion criteria: 1. Patients that present clinical signs of vaginal infections and other vaginal disorders. 2. Patients are currently using product for Vulva Vaginal Dryness (VVD) or VDA. 3. Patients in previous treatment with either oral or topical hormonal products within 1 month. Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc.) in the 4 weeks to 6 months (depending on the product used) prior to study entrance. 4. Positive history of hypersensitivity to any component of the medical device. 5. Presence of other malignancies including cervical, ovarian, and uterine cancers. 6. Operative history of hysterectomy or oophorectomy. 7. Current use of medication for urogynecologic problems. 8. Unexplained vaginal bleeding. 9. Pregnant or breastfeeding. 10. Not having performed any regenerative gynecology technique (laser, radiofrequency or filler insertion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient's perception of the most bothersome symptom at baseline and 12 weeks using Patient's perception of vaginal discomforts evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient's perception of the most bothersome symptom at baseline and 4 weeks using Patient's perception of vaginal discomforts evaluation 2. Patient's perception of the vaginal discomforts at baseline, 4 and 12 weeks of treatment using Patient's perception of vaginal discomforts evaluation. 3. Average score of Vaginal Health Index (VHI) at baseline, 4 and 12 weeks. 4. pH evaluation evaluated by pH strips at baseline, 4 and 12 weeks. 5. Patient's global assessment of overall satisfaction at 4 and 12 weeks of treatment. 6. Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI) at baseline, 4 and 12 weeks. 7. Improvement of quality of life through Cervantes scale’s questionnaire at 4 and 12 weeks. 8. Local tolerability at the application site evaluated by the patient at 4 and 12 weeks. 9. Cosmetic, satisfactory and efficacy questionnaire at 4 and 12 weeks. 10. Safety: collection of S/AE emerged as consequence of the product application and any other adverse event occurred during the study. | — |
Countries
Spain
Contacts
Public ContactJavier Bustos
Outcome results
None listed