Actively Recruiting
A Multicenter, Open, Comparative Study on the Effect of Palomacare ae Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Led by Procare Health Iberia S.L. · Updated on 2025-02-03
30
Participants Needed
2
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates vaginal dysbiosis in premenopausal women with elevated vaginal pH, aiming to see if a non-hormonal topical product can improve vaginal microbiota and help prevent future infections. The study includes women aged 18 to 45 with regular menstrual cycles and examines both symptomatic and asymptomatic cases of dysbiosis. The research is conducted as a multicenter, open, comparative study with random assignment to groups, sponsored by Procare Health Iberia S.L. Participants are divided into three groups: symptomatic women receiving Palomacare ae vaginal gel for 6 days, asymptomatic women receiving the same treatment for 6 days, and asymptomatic women under monitored follow-up without treatment. The study involves two visits: an initial visit between days 9 and 15 of the menstrual cycle and a final visit within 5 days after treatment or equivalent timing for the monitoring group. The trial consists of a pilot phase with 30 patients and an extension phase adding 60 more, totaling 90 participants. During the approximately 11-12 day study period, researchers will assess the effect of Palomacare ae vaginal gel on vaginal microbiota, symptoms, vaginal pH, user satisfaction, and safety. Evaluations include diagnostic tests and symptom monitoring at both visits. Participants will be closely followed for tolerability and response to treatment, with outcomes measured by vaginal microbiota changes and symptom improvement recorded through the study duration.
CONDITIONS
Brief Title
A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 45 years of age, inclusive
- Attending a gynecological visit between days 9 and 15 of the menstrual cycle
- Regular menstrual cycles of 24 to 35 days
- Able to understand and sign informed consent
- Vaginal pH higher than 4.5, with or without symptoms
You will not qualify if you...
- Diagnosis of other vaginal or vulvar conditions that may interfere with study interpretation
- Diagnosis of cervical intraepithelial neoplasia, cervical or endometrial neoplasia
- Active genitourinary infections within 15 days prior to inclusion
- Active genital lesions or genital bleeding
- Pregnant or within 40 days postpartum
- Use of copper IUD for contraception
- Use of oral or topical antibiotics or vaginal antifungals in the 2 weeks before initial visit
- Planned immunosuppressive therapy
- Decompensated chronic diseases (e.g., diabetes, epilepsy, high blood pressure)
- Use of other experimental drugs or devices in the 30 days prior to selection
- Hypersensitivity to any components of the study treatment
- Inability to comply with study requirements due to follow-up or physical/psychological reasons
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 days
Participants receive treatment with Palomacare® vaginal gel for 6 days if assigned to treatment groups. Participants in the monitored follow-up group do not receive treatment.
1 initial visit and 1 final visit within 5 days after treatment or equivalent for monitored follow-up
Duration - Approximately 5 to 6 days after treatment or monitored follow-up
Participants are observed until the end of the study approximately 11 to 12 days after starting the study to assess effects on vaginal microbiota, symptoms, and safety.
Final visit within 5 days after treatment or equivalent
Trial Site Locations
Total: 2 locations
1
Clínica Sagrada Familia
Barcelona, Spain, 08022
Actively Recruiting
2
Instituto Palacios de Salud y Medicina de la Mujer
Madrid, Spain, 41720
Actively Recruiting
Research Team
J
Josep Combalia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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