Cervical Intraepithelial NeoplasiaNCT02907333
Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia
A study testing Advice to use condoms in people with Cervical Intraepithelial Neoplasia, run by University of Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Advice to use condoms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Women with latex allergy
- Women who become pregnant in the study period
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center of Epidemiology and Screening
Copenhagen, Øster Farimagsgade 5, 1014
About this study
Official title: 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.
Read the 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.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Advice to use condoms
- Keywords
- Condom use, Human Papillomavirus, Conization
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advice to use condomsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Women who are advised to use condom during the time period between diagnosis and follow-up Receives: Behavioral: Advice to use condoms |
| Control group | No intervention | Women who are not contacted with advise to use condoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression rate in cervical intraepithelial neoplasia
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.
Measured: 6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)
Secondary outcomes (1)
HPV-clearance
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.
Measured: 6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Malene Skorstengaard, University of Copenhagen
- Investigators
- Elsebeth Lynge, Professor, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907333
- Sponsor's protocol ID
- 102-2880/15-3000
- Status last verified
- Mar 2020
- First submitted
- 14 Sep 2016
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Skorstengaard M, Suhr J, Lynge E. Condom use to enhance regression of cervical intraepithelial neoplasia: study protocol for a randomized controlled trial. Trials. 2019 Aug 2;20(1):473. doi: 10.1186/s13063-019-3564-4.
PubMed 31375148
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Condoms in Prevention of Progression of Cervical Intraepithelial Neoplasia: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02907333
- Acronym / sponsor ID
- 102-2880/15-3000
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Condom use, Human Papillomavirus, Conization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- 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
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Advice to use condomsWomen who are advised to use condom during the time period between diagnosis and follow-up |
| Control group | No intervention | –Women who are not contacted with advise to use condoms |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Women with latex allergy
- Women who become pregnant in the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advice to use condoms | Behavioural | Intervention group |
Primary outcome
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.
1 secondary outcome
HPV-clearance
Time frame: 6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 31375148Skorstengaard M, Suhr J, Lynge E. Condom use to enhance regression of cervical intraepithelial neoplasia: study protocol for a randomized controlled trial. Trials. 2019 Aug 2;20(1):473. doi: 10.1186/s13063-019-3564-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elsebeth Lynge, Professor study director
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice to use condoms in people with Cervical Intraepithelial Neoplasia, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.