Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HP… (NCT04199078) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions.
Spain288 participantsStarted 2019-09-25
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-HR. All the patients included in the study will be randomized (1:1:1:1) in 4 arms.
Who can participate
Age range30 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Woman between the ages of 30 and 65 (both inclusive).
✓. Able to read and understand the Patient Information Sheet and the Informed Consent form.
✓. Acceptance in the participation of the essay and signature of the Informed Consent form.
✓. ASC-US or LSIL or AG-US cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit).
✓. High risk HPV positive by PCR performed at screening visit.
✓. Is able, at the discretion of the researcher, to comply with the requirements of the trial and without hindrance to follow the instructions and assessments 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
Evaluate the repairment of the cervico-vaginal mucosa with concordant colposcopic image