E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Abnormal cervical cells |
Celleforandringer på livmoderhalsen |
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E.1.1.1 | Medical condition in easily understood language |
precancerous cervical lesions |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008229 |
E.1.2 | Term | Cervical cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim is to initiate a blinded study to investigate, if the diagnosis of cervical precancerous lesions can be improved among postmenopausal women aged ≥ 50 years, by providing pretreatment with vaginal estrogen prior to the colposcopic examination. Thereby to reduce the disease burden and prevent cervical cancer. |
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E.2.2 | Secondary objectives of the trial |
This project is important to ensure accuracy and timely diagnosis for women with precancerous cervical lesions. First, this study will address key issues not previously explored about detection of precancerous lesions in order to prevent cervical cancer from developing. Secondly, we believe that the project will contribute with important knowledge that can be incorporated into clinical use, and may help guide future follow-up guidelines on screening programs. Thirdly, the results can help to avoid repetition of surveys, unnecessary inspections, inappropriate follow-up as well as over- and under treatment. Finally, we believe that evidence obtained from this study will help reduce the number of women with late-stage cervical cancer and poor prognosis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Women referred for colposcopy aged ≥ 50 years and postmenopausal. • Women referred for colposcopy due to a positive HPV test and/or an abnormal cervical cytology. • Women referred for colposcopy due to previous abnormal cervical histology with minimum 6. months since last colposcopy with biopsies.
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E.4 | Principal exclusion criteria |
- Women with use of estrogen within the last 3 months. - Pregnancy - Women with previously amputation, conization, radiation or ionization of the cervix |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcomes will be: • Scoring of the visibility of the SCJ by the colposcopist as TZ1, TZ2 and TZ3. • Representation of the TZ in at least 50% of the cervical biopsies from each patient.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After enrollment of approximately 30 women in each group, an inter-rim analysis will be performed. |
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E.5.2 | Secondary end point(s) |
Secondary outcomes will be: • The patients’ report on possible side effects during pretreatment. • The proportionen of CIN2+ found in biopsies. • The proportion of diagnostics conization.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After enrollment of approximately 30 women in each group, an inter-rim analysis will be performed. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Based on statistical consideration the trail will include 75 patients in each group before the study end. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |