An open, single center, clinical investigation to evaluate the efficacy and safety of woman ISDIN Vaginal Moisturizer on symptomatic vaginal atrophy in post menopausal woma

Not Applicable

Completed

• Conditions: Efficacy and safety of Woman ISDIN® Vaginal Moisturizer in the alleviation of vaginal atrophy symptoms; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN78747508
• Lead Sponsor: Isdin (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-04-12
• Study Start: 2024-01-19
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 43

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 <15.
5. Vaginal pH >5.0
6. Women with active sex life.

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).

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Patient's perception of the most bothersome symptom at baseline and 12 weeks using Patient's perception of vaginal discomforts evaluation