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Clinical trial

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

ID
Name
R 180
Description
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.
Trial arms
Trial start
2021-11-13
Estimated PCD
2023-08-01
Trial end
2023-09-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
the first group estrogen group
Other names:
Premarin cream
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.
Arms:
the second group PRP group
Size
100
Primary endpoint
improvement in Vaginal Health Index (VHI).
12 weeks
improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS).
12 week
Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI)
12 week
Eligibility criteria
Inclusion Criteria: * postmenopausal women aged 50-70 years old * with a clinical diagnosis of vaginal atrophy who will not need systemic estrogen therapy for the treatment of vasomotor symptoms or prophylaxis of osteoporosis * Any parity. Exclusion Criteria: * Women with any history of carcinoma of the breast or endometrium, * abnormal genital bleeding, acute thrombophlebitis, or thromboembolic disorders associated with previous estrogen use, * or current urinary. * In addition, women who underwent hormone replacement therapy, treated with systemic or vaginal estrogen within 6 months prior to the study, * or had any contraindication for estrogen therapy will be excluded from the study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized clinical trial that will be performed in a Fayoum university hospital. It includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 pt', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-05-01

1 organization

2 products

2 indications

Organization
Fayoum University
Product
Conjugated Estrogens vaginal cream
Indication
Atrophic Vaginitis
Indication
Vaginal Atrophy
Product
Platelet Rich Plasma