Efficacy of Intravaginal Carboxymethyl-β-glucan and Polycarbophil on Low-grade Cervical Lesions (GLUCANCIN)

Launched by URIACH CONSUMER HEALTHCARE · Feb 24, 2021

Keywords

ClinConnect Summary

Background

Human papillomavirus (HPV) infection represents a significant source of morbidity and mortality worldwide. High-risk oncogenic HPVs cause 99.7% of cervical cancers. 80% of sexually active women will be infected with HPV at some point in their life. Most of these infections are transitory and only if they are persistent and caused by a high-risk oncogenic HPV are they an important risk factor for the development of cervical intraepithelial lesions and invasive cervical cancer. Immunity plays a key factor in eliminating HPV infection. The innate immune response constitutes the fir...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Woman between 30 and 50 years old
• • Capable of understanding the Pacient Information Sheet and the Informed Consent form
• • Accepting her particpation in the study and signing the Informed Consent
• • LSIL/CIN1 hystological result on cervical biopsy preceeded by HR-HPV+ test (genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68)
• • Cervical cytology ≥ ASCUS or precceded by a HPV16+ test and negative cervical cytology for lesion or malignancy but with CIN1 colposcopy and biopsy.
• Exclusion Criteria:
• • Cervical cytology suspicious of invasive cervical cancer
• • Current or previous pregnancy ended before six weeks in relation to the start of the study.
• • Vaccination against HPV.
• • Clinically relevant pathology linked to immunodeficiency.
• • Immunosuppressive treatment active or finished before six months in relation to the start of the study. In the specific case of corticosteroids, all women who are receiving corticosteroid treatment currently or recently (defined as the two weeks prior to the start of the study) or if she has received 2 or more cycles of corticosteroids in equal or greater than 20 mg / day of predsinone (or equivalent) orally or parenterally, for one week duration at least in the year prior to the start of the study. The use of inhaled corticosteroids, Nasal or topical are not exclusion criteria.
• • Undiagnosed abnormal genital bleeding.
• • Total hysterectomy.
• • Presence of genital warts and other symptomatic vulvovaginal infections.
• • Documented history of cervical pathology caused by HPV.
• • Current systemic and / or gynecological disease that contraindicates the use of Colpofix.
• • Contraindications to the use of Colpofix or known allergies to any of its components
• • Simultaneous participating in a clinical study of an investigational drug or that could interfere with the use of Colpofix.