Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With L… (NCT04002154) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV
Spain134 participantsStarted 2015-10-19
Plain-language summary
Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1).
Who can participate
Age range30 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Woman between the ages of 30 and 65 (both included).
✓. Able to read and understand the Patient Information Sheet and the Informed Consent form.
✓. Accept participation in the study and sign the Informed Consent form.
✓. Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
✓. Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
✓. Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations throughout it.
Exclusion criteria
✕. Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
✕. Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
✕. To had been vaccinated against HPV.
✕. Other symptomatic vulvovaginal infections.
✕. Surgical cervical excision in the last year or total hysterectomy.
✕. Previous history of gynecological cancer.
What they're measuring
1
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image