Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT06668012

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

Led by Procare Health Iberia S.L. · Updated on 2025-02-03

30

Participants Needed

2

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 45 years of age, inclusive
  • Attending a gynecological visit in the first phase of the menstrual cycle (days 9 to 15)
  • Regular menstrual cycles of 24 to 35 days
  • Able to understand and sign informed consent
  • Vaginal pH higher than 4.5, with or without symptoms
Not Eligible

You will not qualify if you...

  • Diagnosis of other vaginal or vulvar conditions that could affect study results
  • Cervical intraepithelial neoplasia, cervical carcinoma, or endometrial neoplasia
  • Active genitourinary infections within 15 days prior to inclusion
  • Active genital lesions or genital bleeding
  • Pregnant or within 40 days postpartum
  • Use of copper IUD for contraception
  • Use of oral or topical antibiotics or vaginal antifungals within 2 weeks prior to visit
  • Planned immunosuppressive therapy
  • Decompensated chronic diseases such as diabetes, epilepsy, or high blood pressure
  • Use of experimental drugs or devices within 30 days prior to selection
  • Hypersensitivity to study treatment components
  • Inability to comply with study requirements due to follow-up or psychophysical issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Clínica Sagrada Familia

Barcelona, Spain, 08022

Actively Recruiting

2

Instituto Palacios de Salud y Medicina de la Mujer

Madrid, Spain, 41720

Actively Recruiting

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Research Team

J

Josep Combalia, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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