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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorProcare Health Iberia S.L.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Palomacare® vaginal gel is a medical device with CE class IIa.

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators