RecruitingNot Applicable

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

Spain30 participantsStarted 2024-12-12

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. With a vaginal pH higher than 4.5 with or without symptoms

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of Palomacare® vaginal gel on vaginal microbiota (VM)

Timeframe: Through study completion, an average of 12 days

Trial details

NCT IDNCT06668012

SponsorProcare Health Iberia S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-20

Contact for this trial

Josep Combalia, MD

+34 93 645 54 41 combalia.j@procarehealth.com

View on ClinicalTrials.gov More Vaginal Dysbiosis trials