genitourinary syndrome of menopause
Conditions
Brief summary
The primary efficacy criteria is the percentage of patients with improved symptomatology. Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS) evaluated at 6 months after treatment.
Detailed description
Healing percentage defined as percentage of patients scoring ≥ 15 in the VHIS at 6 months after treatment., Evolution of Vaginal Health Index at 3-months and 6-months follow-up, Evolution of Vulvar Health Index at 3- and 6-months follow-up, Evolution of vaginal pH at 3- and 6-months follow-up, Evolution of Vaginal maturation index (vaginal cytology) at 3- and 6-months follow-up, Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) will be measured using a 5-cm visual analog scale (VAS) at 3- and 6-months follow-up, Evolution of Female Sexual Distress (FSD) score at 3- and 6-months follow-up, Photographic monitoring at 3- and 6-months follow-up
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy criteria is the percentage of patients with improved symptomatology. Improvement is defined as having a higher score than the baseline in the Vaginal Health Index (VHIS) evaluated at 6 months after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Healing percentage defined as percentage of patients scoring ≥ 15 in the VHIS at 6 months after treatment., Evolution of Vaginal Health Index at 3-months and 6-months follow-up, Evolution of Vulvar Health Index at 3- and 6-months follow-up, Evolution of vaginal pH at 3- and 6-months follow-up, Evolution of Vaginal maturation index (vaginal cytology) at 3- and 6-months follow-up, Evolution of intensity of VVA symptoms (vaginal burning, vaginal itching, vaginal dryness, dyspareunia, and dysuria) will be measured using a 5-cm visual analog scale (VAS) at 3- and 6-months follow-up, Evolution of Female Sexual Distress (FSD) score at 3- and 6-months follow-up, Photographic monitoring at 3- and 6-months follow-up | — |
Countries
Spain