NCT03837028: HPVandFSFI

The Human Papilloma Virus Effect on Sexual Life

Completed Results posted Last updated 6 October 2020

What this trial tests

trial testing FSFI in Human Papillomavirus Infection in 127 participants. Completed in 1 October 2018.

Timeline

1 January 2018

Primary endpoint
1 June 2018

1 October 2018

Quick facts

Lead sponsor	Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	127
Start date	1 January 2018
Primary completion	1 June 2018
Estimated completion	1 October 2018
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• FSFI

Conditions studied

• Human Papillomavirus Infection — all drugs for Human Papillomavirus Infection →

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Who can join

Adults 30 to 50, female only, with Human Papillomavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Female Sexual Function Index (FSFI) Score Primary · change from initial overall FSFI score at second months.

This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and

Group	Value	95% CI
HPV 16/18 (+), Cytology Normal	0.8	± 0.5
HPV 16/18 (+), Cytology Abnormal	1.2	± 0.9
Non-16/18 HPV (+), Cytology Abnormal	0.9	± 0.9
Non-16/18 HPV (+), Cytology Normal	0.7	± 0.5

Beck Anxiety Inventory (BAI) Score Secondary · change from initial BAI score at second months.

The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.

Group	Value	95% CI
HPV 16/18 (+), Cytology Normal	4.5	± 3.0
HPV 16/18 (+), Cytology Abnormal	4.8	± 2.3
Non-16/18 HPV (+), Cytology Abnormal	4.1	± 2.1
Non-16/18 HPV (+), Cytology Normal	2.2	± 2.2

Sponsor's own description

Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer. After the HPV test has been used in cervical cancer screening, there have been concerns about whether women carry this virus. Although HPV testing may cause negative emotional responses, adverse emotional responses are related to HPV infection rather than testing. In this respect, there were several studies which evaluated the quality of life and psychological responses of women with positive HPV test results and it is known that positive HPV test results cause additional anxiety, distress and negative emotional responses in women. We hypothesized that the awareness of having a sexually transmitted infection in women with HPV and, therefore, a close follow-up and the need for further investigation such as colposcopy can affect their sexual life. In this study, we aimed to observe the changes in sexual function and anxiety of the HPV positive women with validated objective tools after being informed about their co-test results.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.