A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA) (NCT06668012) | Clinical Trial Compass
RecruitingNot Applicable
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Spain30 participantsStarted 2024-12-12
Plain-language summary
The hypothesis is raised of improving the status of vagnal microbiota with a non-hormonal topical product in early situations of dysbiosis in which the vaginal pH is elevated and the patient may or may not be symptomatic, in order to try to prevent the appearance of future established vaginal infections.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Between 18 and 45 years of age, inclusive.
✓. Who are attending a gynecological visit for any reason and who are in the first phase of the menstrual cycle, between the end of menstruation and before ovulation (approximately between days 9 and 15).
✓. With regular menstrual cycles of between 24 and 35 days.
✓. Who are able to understand and sign the informed consent after the nature of the study has been fully explained to them.
✓. With a vaginal pH higher than 4.5 with or without symptoms
Exclusion criteria
✕. Diagnosis of another vaginal or vulvar condition that may confuse the interpretation of the response to the investigational product (erosive lichen planus, inflammatory desquamative vaginitis, or contact dermatitis involving the vulvar epithelium).
✕. Diagnosis of cervical intraepithelial neoplasia (CIN), cervical carcinoma, or endometrial neoplasia.
✕. Active genitourinary infections (VVC, N. gonorrhoeae, C. trachomatis, or T. vaginalis) at the time of inclusion or within 15 days prior to inclusion in the study.
✕. Active genital lesions (ulcers or vesicles compatible with herpes or warts) or genital bleeding.
✕. Pregnant patients or in the immediate postpartum period (up to 40 days).
✕. Contraception with copper IUD.
What they're measuring
1
Effect of Palomacare® vaginal gel on vaginal microbiota (VM)
Timeframe: Through study completion, an average of 12 days