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RECRUITING
NCT06668012
NA

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

Sponsor: Procare Health Iberia S.L.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-12-12

Completion Date

2025-05-31

Last Updated

2025-02-03

Healthy Volunteers

No

Interventions

DEVICE

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

The duration of the study for each patient will be approximately 11-12 days and the treatment for groups A and B will be 6 days. In a first pilot study in asymptomatic women, a tendency towards a positive effect on the composition of vaginal fluid was already observed, as assessed by diagnostic tests and classified using a Likert scale. A subsequent study showed that treatment with a different vaginal gel but with an identical concentration of ingredients from Palomacare® vaginal gel, for 21 consecutive days, is able to improve the composition of vaginal fluid. Based on these preliminary data, it is possible to hypothesize that the action of Palomacare® vaginal gel will have a positive effect on the composition of vaginal fluid in patients affected by dysbiosis, whether asymptomatic or not.

Locations (2)

Clínica Sagrada Familia

Barcelona, Spain

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, Spain