Trial Outcomes & Findings for The Human Papilloma Virus Effect on Sexual Life (NCT NCT03837028)

Results Overview

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 six domain scores are our first primer outcomes.

Recruitment status

COMPLETED

Target enrollment

127 participants

Primary outcome timeframe

change from initial overall FSFI score at second months.

Results posted on

2020-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Human Papillomavirus (HPV) 16/18 (+), Cytology Normal Women who have Human papillomavirus (HPV) (16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Human Papillomavirus (HPV)16/18 (+), Cytology Abnormal Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 Human Papillomavirus (HPV) (+), Cytology Abnormal Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 Human Papillomavirus (HPV) (+), Cytology Normal Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Overall Study STARTED	35	34	33	25
Overall Study COMPLETED	19	23	20	18
Overall Study NOT COMPLETED	16	11	13	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Human Papillomavirus (HPV) 16/18 (+), Cytology Normal Women who have Human papillomavirus (HPV) (16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Human Papillomavirus (HPV)16/18 (+), Cytology Abnormal Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 Human Papillomavirus (HPV) (+), Cytology Abnormal Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 Human Papillomavirus (HPV) (+), Cytology Normal Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The Female Sexual Function Index (FSFI) and Beck Anxiety Inventory (BAI) questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered FSFI Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Overall Study Lost to Follow-up	4	0	2	0
Overall Study Withdrawal by Subject	12	11	11	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HPV 16/18 (+), Cytology Normal n=19 Participants Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	HPV 16/18 (+), Cytology Abnormal n=23 Participants Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 HPV (+), Cytology Abnormal n=20 Participants Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 HPV (+), Cytology Normal n=18 Participants Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Total n=80 Participants Total of all reporting groups
Age, Continuous	38.2 years STANDARD_DEVIATION 5.6 • n=19 Participants	37.7 years STANDARD_DEVIATION 4.9 • n=23 Participants	36.6 years STANDARD_DEVIATION 4.8 • n=20 Participants	40.1 years STANDARD_DEVIATION 4.5 • n=18 Participants	38.1 years STANDARD_DEVIATION 5.0 • n=80 Participants
Sex: Female, Male Female	19 Participants n=19 Participants	23 Participants n=23 Participants	20 Participants n=20 Participants	18 Participants n=18 Participants	80 Participants n=80 Participants
Sex: Female, Male Male	0 Participants n=19 Participants	0 Participants n=23 Participants	0 Participants n=20 Participants	0 Participants n=18 Participants	0 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Overall Female Sexual Function Index Score	25.2 scores on a scale n=19 Participants	27.1 scores on a scale n=23 Participants	23.8 scores on a scale n=20 Participants	23 scores on a scale n=18 Participants	25.1 scores on a scale n=80 Participants

PRIMARY outcome

Timeframe: 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 six domain scores are our first primer outcomes.

Outcome measures

Outcome measures
Measure	HPV 16/18 (+), Cytology Normal n=19 Participants Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	HPV 16/18 (+), Cytology Abnormal n=23 Participants Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 HPV (+), Cytology Abnormal n=20 Participants Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 HPV (+), Cytology Normal n=18 Participants Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Female Sexual Function Index (FSFI) Score	0.8 score on a scale Standard Deviation 0.5	1.2 score on a scale Standard Deviation 0.9	0.9 score on a scale Standard Deviation 0.9	0.7 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HPV 16/18 (+), Cytology Normal n=19 Participants Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	HPV 16/18 (+), Cytology Abnormal n=23 Participants Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 HPV (+), Cytology Abnormal n=20 Participants Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.	Non-16/18 HPV (+), Cytology Normal n=18 Participants Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later. FSFI: Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Beck Anxiety Inventory (BAI) Score	4.5 score on a scale Standard Deviation 3.0	4.8 score on a scale Standard Deviation 2.3	4.1 score on a scale Standard Deviation 2.1	2.2 score on a scale Standard Deviation 2.2

Adverse Events

HPV 16/18 (+), Cytology Normal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HPV 16/18 (+), Cytology Abnormal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-16/18 HPV (+), Cytology Abnormal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-16/18 HPV (+), Cytology Normal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ismail Alay

bakirkoy dr sadi konuk training and research hospital

Phone: +905462375638

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place