Abnormal cervical cells MedDRA version: 21.1 Level: LLT Classification code 10008229 Term: Cervical cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Vagifem
Pharmaceutical Form: Vaginal capsule
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
Other descriptive name: Estradiol
Concentration unit: µg microgram(s)
Concentration type: equal
Conc
Sponsors
Randers Regional Hospital, Department of Gynecology and Obstetrics
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Women with use of estrogen within the last 3 months. - Pregnancy - Women with previously amputation, conization, radiation or ionization of the cervix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;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. ;Timepoint(s) of evaluation of this end point: After enrollment of approximately 30 women in each group, an inter-rim analysis will be performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: After enrollment of approximately 30 women in each group, an inter-rim analysis will be performed. | — |
Countries
Denmark
Contacts
Public ContactVibe Munk Bertelsen
Randers Regional Hospital, Department of Gynecology and Obstetrics
Outcome results
None listed