NCT05118685

Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fayoum University · Academic / Other
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Oestrogen deficiency affects many organs such as the genitourinary system. Genitourinary involvement causes untoward symptoms of atrophic vaginitis including dryness, burning, dyspareunia, vulvar pruritus, and discharge For this reason, many investigations have been performed to find out effective, safe, and acceptable therapeutic methods for atrophic vaginitis. Although systemic administration of estrogen can improve the localized symptoms of atrophic vaginitis, women are often reluctant to use systemic hormone replacement therapy and prefer local administration of estrogen. Vaginal application of estrogen has been considered an effective treatment of atrophic vaginitis. The effects of PRP treatment have been evaluated in many clinical conditions, including wound healing, hair repair, skin regeneration \[9\], vulvar lichen sclerosis, stress urinary incontinence, episiotomy scars, and lubrication aging in the vagina. It can take at least 12 weeks to determine the final effects of treatment with PRP Population of Study It includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 pt Methodology in detail: Patients of the first group will receive vaginal estrogen cream one tube every night for 14 nights; then, one tube 2 nights in 1 week (two tubes every week) for 10 weeks. The second group will receive PRP injection every 3 weeks for 4 times. PRP will be administered to the anterior vaginal wall using 27-G needles once every 3 weeks for 4 times and PRP is mainly injected into the clitoris or the anterior wall of the vagina to increase the tactile sensitivity of the injection site.

Conditions

• Atrophic Vaginitis
• Postmenopausal Atrophic Vaginitis

Interventions

Type	Name	Description
DRUG	Conjugated Estrogens vaginal cream 0,625mg	the particepant will receive vaginal estrogen cream one tube every night for 14 nights; then, one tube for 2 nights in 1 week (two tubes every week) for 10 weeks.
COMBINATION_PRODUCT	platelet rich plasma	First, a topical anesthetic cream will be applied to the vaginal wall. Delaying the PRP injection for 20 minutes after anesthetics application achieved complete or near-complete analgesia for the procedure. Peripheral blood will be drawn from the arm and centrifuged to yield 5 cc of PRP. then PRP will be administered to the anterior vaginal wall using 27-G needles once every 3 weeks for 4 times and PRP is mainly injected into the anterior wall of the vagina to increase the tactile sensitivity of the injection site.

Timeline

• Start date: 2021-11-13
• Primary completion: 2023-08-01
• Completion: 2023-09-01
• First posted: 2021-11-12
• Last updated: 2023-05-01

Locations

2 sites across 1 country: Egypt