Clinical trial NCT06668012: A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Official title: A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vaginal Dysbiosis
Keywords: Vaginal
Palomacare
Dysbiosis
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, open, comparative study, where all eligible patients with vaginal dysbiosis (vaginal pH \>4.5) will be assigned to one of the 3 study groups (1:1:1) according to the randomization list for random assignment to groups B and C:

A. Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up
Primary purpose: TREATMENT

Brief 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.

Detailed description: Multicenter, open, comparative study, where all eligible patients with vaginal dysbiosis (vaginal pH \>4.5) will be assigned to one of the 3 study groups (1:1:1) according to the randomization list for random assignment to groups B and C:

A. Symptomatic patients: Treatment with Palomacare® vaginal gel for 6 days B. Asymptomatic patients: Treatment with Palomacare® vaginal gel for 6 days C. Asymptomatic patients: Monitored follow-up

2 visits will be made throughout the study: visit 1 (initial visit, between days 9 and 15 of the menstrual cycle) and visit 2 (final visit, within 5 days after the end of treatment or equivalent in the case of the monitored follow-up group, always before the next menstruation).

The study will consist of two phases; the first phase or PILOT, where 30 patients (10 per group) will be included with the intervention of 2 centers, and a second phase or EXTENSION, where 60 additional patients (20 per group) will be included, obtaining a total of 90 patients (30 per group) at the end of the study.

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.

Primary outcomes:
measure: Effect of Palomacare® vaginal gel on vaginal microbiota (VM)
timeFrame: Through study completion, an average of 12 days
Secondary outcomes:
measure: Effect of Palomacare® vaginal gel on symptoms and pH
timeFrame: Through study completion, an average of 12 days
measure: Satisfaction with the use of Palomacare® vaginal gel
timeFrame: Through study completion, an average of 12 days
measure: Safety and tolerability of Palomacare® vaginal gel
timeFrame: Through study completion, an average of 12 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clínica Sagrada Familia
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
Study officials:
affiliation: Instituto Palacios de Salud y Medicina de la Mujer
name: Dr. Santiago Palacios Gil-Antuñano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Sagrada Familia
name: Dr. Fernando Losa Domínguez, MD
role: PRINCIPAL_INVESTIGATOR
References: