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The efficacy of the use of Cellular Matrix-BCT-HA (combination of autologous platelet-rich plasma and non-cross-linked hyaluronic acid) compared to local estrogen therapy (Blissel, estriol 50 micrograms/g vaginal gel) in women with genitourinary syndrome of menopause. A randomized controlled trial, with a second blind observer.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507200-31-00
Acronym
FSD-CEL-2023-11
Enrollment
192
Registered
2024-04-26
Start date
2024-05-24
Completion date
Unknown
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

genitourinary syndrome of menopause

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

DRUGBlissel 50 microgramos/g gel vaginal.

Sponsors

Santiago Dexeus Font Fundacio Privada
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026