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Clinical Trials in Spain / NCT06668012
Recruiting Not applicable

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

NCT06668012 · tracked via the Priya Life Science Spain tracker
Sponsor
Procare Health Iberia S.L
Phase
Not applicable
Started
2024-12-12
Last updated
2025-02-03

Condition(s) studied

Vaginal Dysbiosis

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: 1. Between 18 and 45 years of age, inclusive. 2. 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). 3. With regular menstrual cycles of between 24 and 35 days. 4. Who are able to understand and sign the informed consent after the nature of the study has been fully explained to them. 5. With a vaginal pH higher than 4.5 with or without symptoms Exclusion Criteria: 1. 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). 2. Diagnosis of cervical intraepithelial neoplasia (CIN), cervical carcinoma, or endometrial neoplasia. 3. 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. 4. Active genital lesions (ulcers or vesicles compatible with herpes or warts) or genital bleeding. 5. Pregnant patients or in the immediate postpartum period (up to 40 days). 6. Contraception with copper IUD. 7. Use of oral or topical antibiotics, or vaginal antifungals in the two weeks prior to the initial visit. 8. Planned immunosuppressive therapy. 9. Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.). 10. Use of any other experimental drug or device during the 30 days prior to selection. 11. Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatments. 12. 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.

Primary outcome measure(s)

  • Effect of Palomacare® vaginal gel on vaginal microbiota (VM) — Through study completion, an average of 12 days
    To evaluate the effect of Palomacare® vaginal gel on VM, the change in microbial diversity, vaginotype and taxonomic profile of the vaginal microbiome will be analyzed between V1 and V2 in each group.

Trial sites (2)

FacilityCityRegionStatus
Clínica Sagrada Familia Barcelona Spain Recruiting
Instituto Palacios de Salud y Medicina de la Mujer Madrid Spain Recruiting

More Procare Health Iberia S.L. trials in Spain

Observational Study to Evaluate Fertility in Women Between 32 and 38 Years Old Treated With the Ovosicare® Fertility Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06668012 on ClinicalTrials.gov ↗ ← All trials in Spain