A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPAL
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.
| Condition(s) | Vaginal Dysbiosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. Between 18 and 45 years of age, inclusive. 2. 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). 3. With regular menstrual cycles of between 24 and 35 days. 4. Who are able to understand and sign the informed consent after the nature of the study has been fully explained to them. 5. With a vaginal pH higher than 4.5 with or without symptoms Exclusion Criteria: 1. 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). 2. Diagnosi |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Lead sponsor | Procare Health Iberia S.L. |
| Locations | Barcelona, Spain; Madrid, Spain |
| Start date | 2024-12-12 |
| NCT ID | NCT06668012 |
| Official listing | https://clinicaltrials.gov/study/NCT06668012 |