Improving vaginal microbiota in premenopausal women with dysbiosis

A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)

This study is testing a new vaginal gel to see if it can help premenopausal women with imbalanced vaginal bacteria and prevent future infections.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Procare Health Iberia S.L. (Industry-sponsored)
• Locations: 2 sites (Barcelona and 1 other locations)
• Trial ID: NCT06668012 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 18 to 45 with a vaginal pH higher than 4.5, attending a gynecological visit during the first phase of their menstrual cycle.

Not a fit: Patients with other vaginal or vulvar conditions, active infections, or certain neoplasias will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help restore healthy vaginal microbiota and prevent future infections in women experiencing dysbiosis.

How similar studies have performed: While this approach is novel, similar studies have shown promise in addressing vaginal dysbiosis with topical treatments.

Eligibility criteria

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 this trial is running

Barcelona and 1 other locations

• 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

Conditions Vaginal Dysbiosis; Vaginal; Palomacare; Dysbiosis