Mono-centre, open-label study to investigate the multi-dose pharmacokinetics, efficacy and safety of Interferon alpha-2b Cream in women with a history of cytological diagnosed Pap IIID, with a confirmed histological diagnosis of CIN I or II, and of confirmed HPV+ status - Interferon alpha-2b kinetics in Pap IIID wome

• Conditions: cervical dysplasia (CIN I or CIN II; MedDRA version: 9.1Level: LLTClassification code 10008263Term: Cervical dysplasia; Pap IIID in the history, confirmed HPV+ status)

• Registration Number: EUCTR2008-006208-52-DE
• Lead Sponsor: Helix BioPharma Cooperation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-09
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Female, pre-menopausal subjects aged 18 to 45 years inclusive
- Cytological diagnosis of Pap IIID (Munich nomenclature II) not older than 12 months
- Mild cervical dysplasia (CIN I) or moderate cervical dysplasia (CIN II) confirmed by histology
- HPV+ status confirmed by Hybrid Capture® 2 HPV Deoxyribonucleic Acid (DNA)-Test (Digene®)
- Subjects must be on stable hormonal contraception, which guarantees 29 consecutive days without menstruation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- No Ccytological diagnosis of Pap IIID within the last 12 months or at screening
- Severe dysplasia (CIN III), carcinoma in situ or invasive carcinoma
- History of abnormal Pap smears higher than Pap IIID
- History of or current internal or external urogenital warts
- History of frequently recurrent or current sexually-transmitted infection(s) or bacterial vaginosis
- History or presence of other malignancies
- History or presence of an immune-compromising disease, or a positive Human Immunodeficiency Virus (HIV) test result at screening
- History of Hepatitis B or C, or a positive Hepatitis B or Hepatitis C test result at screening
- Any other treatment of the cervical lesion during study participation (e.g. conization, laser ablation)
- Contraindication for the use of hormonal contraceptives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the pharmacokinetic (PK) profile of Interferon alpha-2b Cream in women with cytological diagnosis of Papanicolaou (Pap) IIID and confirmed Human Papillomavirus positive (HPV+) status;Secondary Objective: To investigate the efficacy and safety of Interferon alpha-2b Cream ;Primary end point(s): Assessment of systemic levels of interferon alpha-2b