Improving vaginal microbiota in premenopausal women with dysbiosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a non-hormonal topical product, Palomacare® vaginal gel, on vaginal dysbiosis in premenopausal women. Participants with elevated vaginal pH will be randomly assigned to receive either the treatment or monitored follow-up. The study consists of two phases, starting with a pilot phase involving 30 patients, followed by an extension phase that will include an additional 60 patients. The aim is to assess whether the treatment can prevent future vaginal infections by improving the vaginal microbiota.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Dr. Santiago Palacios Gil-Antuñano, MD — Instituto Palacios de Salud y Medicina de la Mujer
• Study coordinator: Josep Combalia, MD
• Email: combalia.j@procarehealth.com
• Phone: +34 93 645 54 41

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FB301 for a Lactobacillus-dominant vaginal microbiome in a mock FET cycle

  This trial tests whether FB301 can help shift the vaginal bacteria toward Lactobacillus dominance in women with vaginal dysbiosis during a pretend embryo transfer cycle.

  Recruiting at 3 sites Phase 2 Freya Biosciences ApS · Wichita, Kansas and 3 other locations · NCT07453069

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.