Clinical Trial: Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Use of Condoms in Prevention of Progression of Cervical Intraepithelial Neoplasia: A Randomized Controlled Trial.
Brief Summary:
Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 3-6 months after the diagnosis with new examinations. The regression rate is based solely on the woman's own ability to clear the cervical lesions. The use of condoms has shown a relatively good protective effect against Human Papillomavirus (HPV) infection. It has furthermore been indicated that condoms increase the regression rate of cervical lesions.
The hypothesis of this study is that the regression rate of cervical intraepithelial neoplasia grade 2 (CIN2) increases when condoms are used consistently in the follow-up period of 3-6 months.
Detailed Summary:
Use of condoms has shown a considerable protective effect, when used correctly and consistently, against several sexually transmitted infections (STI), including HIV virus, trichomoniasis, chlamydia, and gonorrhea. It has been indicated that use of condoms also offers a relatively good protection against HPV infections. It is furthermore indicated that use of condoms in women with CIN may increase the regression rate of these lesions.
The aim of this randomized controlled trial is to determine if advising women to use condoms during the follow-up period after a CIN2 diagnosis will increase the regression rate. The advice is based on the presumption that condom use will prevent HPV-infection and reinfection to some extent and thereby allow the immune system to clear the HPV-infection and "repair" the CIN-lesion. Based on the literature, we expect regression in non-condom users to be around 22% and regression in condom-users to be 2.5 times larger.
The clinical trial will be conducted as a randomized non-blinded controlled trial. The study will be conducted at hospital- and gynecological outpatient clinics in Central Region Denmark and Region Zealand.
The gynaecologists will obtain oral and written consent from women with an abnormal cytology to allow the project physician to contact them by telephone. The written consent will be compared to a list from the national pathology register for all diagnosed CIN2 in the relevant regions. If there is a match between the two documents, the gynecologists will be contacted to find out if the woman has been informed about the biopsy result and a follow-up after 3-6 months has been decided. If this is the case, the woman will be included in the study and randomized.
We expect 70
Sponsor: University of Copenhagen
Current Primary Outcome: Regression rate in cervical intraepithelial neoplasia [ Time Frame: 3-6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: HPV-clearance [ Time Frame: 3-6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2) ]
Original Secondary Outcome: Same as current
Information By: University of Copenhagen
Dates:
Date Received: September 14, 2016
Date Started: September 2016
Date Completion: September 2019
Last Updated: September 19, 2016
Last Verified: September 2016