Atrophic Vaginitis Clinical Trial
Official title:
A Comparative Study of Vaginal Oestrogen Cream and Platelet Rich Plasma in Treatment of Atrophic Vaginitis in Fayoum University Hospital
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Fayoum university | Fayoum | |
Egypt | Fayoum university faculity of medicine | Fayoum | Fayoum University Zone |
Lead Sponsor | Collaborator |
---|---|
Fayoum University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | improvement in Vaginal Health Index (VHI). | 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 | 12 weeks | |
Primary | improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS). | 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. | 12 week | |
Primary | Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI) | 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. | 12 week | |
Secondary | Assessment of tolerability and safety of Platelet rich plasma (PRP). | it is measured by the rate of "dropouts", or patients that forfeit participation in a study due to adverse effects (pain during application of the medication, vaginal infection, haematoma formation at site of injection, vaginal spotting, vaginal leakage of the medication and need to use sanitary towels to clean leakage | 12 weeks | |
Secondary | Assessment of tolerability and safety of estrogen vaginal cream | it is measured by the rate of "dropouts", or patients that forfeit participation in a study due to adverse effects (pain during application of the medication .vaginal spotting, vaginal leakage of the medication and need to use sanitary towels to clean leakage | 12 weeks |
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