Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia

March 24, 2020 updated by: Malene Skorstengaard, University of Copenhagen

Use of Condoms in Prevention of Progression of Cervical Intraepithelial Neoplasia: A Randomized Controlled Trial.

Women who are diagnosed with CIN2 and who have a pregnancy wish are followed up 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 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 6 months has been decided. If this is the case, the woman will be included in the study and randomized.

We expect 700 women to be randomized into an intervention- and a control arm. Women in the intervention arm will receive information about the project by telephone by the project physician. The intervention arm will thereafter be subdivided into a condom group and a non-condom group based on the women's acceptance of the intervention. Women in the condom group will be provided with free condoms for the entire study period. The project physician will not contact women in the control group.

From the routine samples taken at the first visit and at the follow-up examination, an HPV test will be requested from the pathology departments for the women in the condom group. The women are also asked to fill out a questionnaire at the follow-up. The information from the questionnaire is used to estimate compliance to the condom use and to have background information about the women in the condom group.

The study is approved by the Data Protection Agency and the Ethical Committee of the Capital Region of Denmark. The total period of time in which the trial is planned to include women is one year having the last woman to her follow-up visit 18 months after the beginning of the trial. The inclusion period is expected to commence 15.09.16 and end 15.09.17.

Randomization will be conducted electronically by the statistician of the department but neither the investigator nor the patient will be blinded as it is not possible for this study design. Data for the study will be collected from registers and from the questionnaires. All final results from the study will be published in relevant international journals.

The project is supported by funds and we have received a sponsorship for condoms. The sponsors had no influence on the study design, and will have no influence on the data collection, analysis and reporting.

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Øster Farimagsgade 5
      • Copenhagen, Øster Farimagsgade 5, Denmark, 1014
        • Center of Epidemiology and Screening

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Premenopausal women with CIN2 diagnosed at colposcopy, biopsy and cytology by participating gynaecologist and pathologists and for whom it has been decided to follow-up 6 months later with new examinations at the gynaecologist.

Exclusion Criteria:

  • Women with latex allergy
  • Women who become pregnant in the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group
Women who are advised to use condom during the time period between diagnosis and follow-up
Behavioral: Advice to use condoms
NO_INTERVENTION: Control group
Women who are not contacted with advise to use condoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression rate in cervical intraepithelial neoplasia
Time Frame: 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 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.
6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV-clearance
Time Frame: 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 6 months follow-up. Association between CIN2 regression and high-risk HPV clearance will be analysed.
6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: 6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)
The questionnaire variables as predictors of CIN2 regression and as predictors of high-risk HPV clearance.
6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Hospital - and gynaecological out-patient clinics in Central Region Denmark
Hospital - and gynaecological out-patient clinics in Region Zealand
Research grant from Fonden for Faglig Udvikling af Speciallægepraksis
Research grant from Kræftens Bekæmpelse
Sponsorship for condoms from RFSU

Investigators

  • Study Director: Elsebeth Lynge, Professor, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

September 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (ESTIMATE)

September 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102-2880/15-3000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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