A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
A Multicenter, Open, Comparative Study on the Effect of Palomacare® Vaginal Gel on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)
Procare Health Iberia S.L.
30 participants
Dec 12, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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).
- Diagnosis of cervical intraepithelial neoplasia (CIN), cervical carcinoma, or endometrial neoplasia.
- 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.
- Active genital lesions (ulcers or vesicles compatible with herpes or warts) or genital bleeding.
- Pregnant patients or in the immediate postpartum period (up to 40 days).
- Contraception with copper IUD.
- Use of oral or topical antibiotics, or vaginal antifungals in the two weeks prior to the initial visit.
- Planned immunosuppressive therapy.
- Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.).
- Use of any other experimental drug or device during the 30 days prior to selection.
- Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatments.
- 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.
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Interventions
The duration of the study for each patient will be approximately 11-12 days and the treatment for groups A and B will be 6 days. In a first pilot study in asymptomatic women, a tendency towards a positive effect on the composition of vaginal fluid was already observed, as assessed by diagnostic tests and classified using a Likert scale. A subsequent study showed that treatment with a different vaginal gel but with an identical concentration of ingredients from Palomacare® vaginal gel, for 21 consecutive days, is able to improve the composition of vaginal fluid. Based on these preliminary data, it is possible to hypothesize that the action of Palomacare® vaginal gel will have a positive effect on the composition of vaginal fluid in patients affected by dysbiosis, whether asymptomatic or not.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06668012