Status:
UNKNOWN
Efficacy of Intravaginal Carboxymethyl-β-glucan and Polycarbophil on Low-grade Cervical Lesions (GLUCANCIN)
Lead Sponsor:
Uriach Consumer Healthcare
Collaborating Sponsors:
Hospital Universitario Infanta Leonor
Hospital Universitario 12 de Octubre
Conditions:
Human Papilloma Virus
Eligibility:
FEMALE
30-50 years
Phase:
NA
Brief Summary
A therapeutic strategy to neutralize the evasion mechanisms of HPV. Among these treatments are beta-glucans, polysaccharides of beta-D-glucose that, can influence the clearance of HPV. The objective o...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04771546
Start Date
June 15 2021
End Date
December 1 2023
Last Update
June 16 2021
Active Locations (5)
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1
Hospital Universitario Infanta Leonor
Vallecas, Madrid, Spain, 28031
2
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
3
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
4
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041