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) ]

Difference in regression of CIN2 between the intervention- and control group. Regression is defined as less than CIN2 diagnosis at the 3-6 months follow-up. For the primary outcome an intention-to-treat analysis will be performed when comparing the intervention group with the control group. Furthermore two per-protocol analysis will be performed. One defining the per-protocol group as those who agreed to use condoms and one defining the per-protocol group who retrospectively reported to use the condoms. Both analysis will be made with control for selection bias.


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) ]

High-risk HPV clearance (type 16,18 or other high-risk types) in the condom user group. Clearance is defined as no high-risk HPV at the 3-6 months follow-up. Association between CIN2 regression and high-risk HPV clearance will be analysed.


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