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

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 12, 2024

Primary Completion Date

May 20, 2025

Study Completion Date

May 31, 2025

Conditions
Vaginal Dysbiosis
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."

Trial Locations (2)

41720

RECRUITING

Instituto Palacios de Salud y Medicina de la Mujer, Madrid

08022

RECRUITING

Clínica Sagrada Familia, Barcelona

All Listed Sponsors
lead

Procare Health Iberia S.L.

INDUSTRY