A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)

Recruiting now · Not applicable

Conditions studied: Vaginal Dysbiosis

In brief

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.

Key facts

Study ID

NCT06668012

Run by

Procare Health Iberia S.L.

People needed

30

Starts

2024-12-12

Expected to finish

2025-05-31

Last updated by the study team

2025-02-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Use of oral or topical antibiotics, or vaginal antifungals in the two weeks prior to the initial visit.
• Planned immunosuppressive therapy.
• Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.).
• Use of any other experimental drug or device during the 30 days prior to selection.
• Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatments.
• Inability, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems or due to psychophysical characteristics.

Where it is running

• Clínica Sagrada Familia — Barcelona, Spain (enrolling)
• Instituto Palacios de Salud y Medicina de la Mujer — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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