Testing Use of Condoms on Regression of Cervical Intraepithelial Neoplasia

NCT02907333 | Completed

• 1 other identifier: 102-2880/15-3000
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Condom use; Human Papillomavirus; Conization

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)

Secondary Outcomes (1)

• HPV-clearance

  6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)

Other Outcomes (1)

• Questionnaire

  6 months follow-up period (The follow-up period at the gynaecologist after the diagnosis of CIN2)

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Women who are advised to use condom during the time period between diagnosis and follow-up

Behavioral: Advice to use condoms

Control group

NO INTERVENTION

Women who are not contacted with advise to use condoms

Interventions

Advice to use condoms BEHAVIORAL

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• Hospital - and gynaecological out-patient clinics in Central Region Denmark: collaborator
• Hospital - and gynaecological out-patient clinics in Region Zealand: collaborator
• Research grant from Fonden for Faglig Udvikling af Speciallægepraksis: collaborator
• Research grant from Kræftens Bekæmpelse: collaborator
• Sponsorship for condoms from RFSU: collaborator

Study Sites (1)

Center of Epidemiology and Screening

Copenhagen, Øster Farimagsgade 5, 1014, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31375148 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Elsebeth Lynge, Professor

  University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)