A Comparative Study of Vaginal Oestrogen Cream and Platelet Rich Plasma in Treatment of Atrophic Vaginitis in Fayoum University Hospital

NCT05118685 Phase 1 UNKNOWN

This study is designed to compare the efficacy, acceptability, and safety of vaginal estrogen cream and platelet-rich plasma in pt. complaining of atrophic vaginitis.

Details

Lead sponsor	Fayoum University
Phase	Phase 1
Status	UNKNOWN
Enrolment	100
Start date	2021-11-13
Completion	2023-09

Conditions

• Atrophic Vaginitis
• Postmenopausal Atrophic Vaginitis

Interventions

• Conjugated Estrogens vaginal cream 0,625mg
• platelet rich plasma

Primary outcomes

• improvement in Vaginal Health Index (VHI). — 12 weeks
  Vaginal Health Index (VHI) will be assessed at weeks 0, 4, 8 and 12. VHI analyzes the following five components on a scale of 1 to 5: elasticity, fluid volume, pH, epithelial integrity, and moisture.A minimal total score of 5 points indicates severe VVA, and a maximal total score of 25 points indicates no clinical signs of VVA
• improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS). — 12 week
  Vulvovaginal atrophy (VVA) will be assessed at weeks 0, 4, 8 and 12. Participants will report intensity of VVA symptoms using a 10-cm VAS. The scale's left extremity indicates the complete absence of symptoms (0) and the right extremity indicates the worst possible symptom (10). Participants rated VVA symptoms (dyspareunia, dryness, or burning) from 0 to 10.
• Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI) — 12 week
  The FSFI will be assessed at weeks 0,4 ,8 and 12 BY FSFI questionnaire addresses six different domains (desire, arousal, lubrication, orgasm, satisfaction, and pain/ discomfort) ranging from 0 (no sexual activity in the past 4 wk) or 1 (very dissatisfied) to 5 (very satisfied). Full scale scores ranging from 2.0 (severe dysfunction) to 36.0 (absence of dysfunction) will be used to evaluate sexual function throughout the study, with increased FSFI scores correlating to an improvement of symptoms. An optimal cut score of 26, reported by Wiegel etal, is currently used to differentiate between women with and without sexual dysfunction.

Countries

Egypt