A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)

Launched by PROCARE HEALTH IBERIA S.L. · Oct 30, 2024

Keywords

ClinConnect Summary

The DISPALOMA clinical trial is studying a non-hormonal topical product aimed at improving the balance of vaginal bacteria in premenopausal women who have a condition called vaginal dysbiosis. This condition can occur when the natural bacteria in the vagina become unbalanced, often indicated by a higher vaginal pH level. The goal is to see if this product can help prevent future vaginal infections in women who may or may not have symptoms.

To participate in the trial, women between the ages of 18 and 45 who are visiting a gynecologist and are in the first half of their menstrual cycle may be eligible. Important criteria include having a vaginal pH higher than 4.5 and being able to understand the study's purpose. Participants will receive instructions about the product and will be monitored throughout the study. It’s important to note that certain conditions, such as active infections or ongoing treatments that could interfere with the study, may exclude some women from participating. This trial is currently recruiting participants, and those who join will contribute to understanding how to better manage vaginal health.

Gender

FEMALE

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.