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CompletedNCT04796090Updated Mar 15, 2021

Genital Wart and Sexuality in Adolescence

An observational study in Adolescent Development, Genital Wart and Sexual Dysfunction, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to female participants aged 17 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-15.

Sponsored by Ankara City Hospital Bilkent · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
17 Years to 21 Years
Sex
Female
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Study summary

The adolescence is a landmark in perceiving the sexuality and awareness about the sexual experiences. Genitals warts were shown to be a potential risk to impair the sexual functions in women. Adolescence is a vulnerable period in which the individuals may be prone to the negative effects of the disorders affecting sexual functions such as genital warts. The current study aimed to investigate the impact of genital warts on sexual functions in female adolescents.

Read the detailed description

This current study aimed to elucidate the impact of genital warts on female sexual function in adolescence. The current study also targeted to reveal whether there is any correlation between the genital warts and the female sexual dysfunction, as well as the sexuality related distress. The current study is conducted at Youth Center Outpatient Clinic of Ankara City Hospital which is a high-volume tertiary health care center in Turkey. The study was prospectively designed and data were collected between the 1 August 2020 and 1 February 2021. Totally 90 female adolescents between the age of 17-21 who had regular sexual intercourse with heterosexual partners were included. The Study group composed of 45 adolescents who had genital warts and the Control group included 45 healthy adolescents. Female sexual function Index (FSFI), Arizona Sexual Experiences Scale (ASEX) and Female Sexual Dysfunction Scale (FSDS) scores were compared between the two groups to evaluate the sexual functions. Difference between two independent means (two groups) power analysis demonstrated that this study achieved a power of 0.99, 0.98 , 0.99 with a 5% level of significance for comparison of 45 adolescents with genital warts and 45 healthy adolescents in terms of FSFI, ASEX, and FSDS scores, respectively.

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Conditions studied

  • Adolescent Development
  • Genital Wart
  • Sexual Dysfunction
  • Sexual Disorder, Physiological

Keywords

  • Genital wart
  • Female sexual dysfunction
  • Late adolescence
  • Sexuality related distress
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In context

Warts

180 studies on the registry are indexed under Warts; 28 are open to participants now.

This study's enrollment of 90 is below the median of 153 across 16 observational studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 21 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The current study included 45 adolescents with the diagnosis of genital warts as the Study group and 45 healthy adolescents as the Control group.

Inclusion criteria

  • The Study group included adolescents who was diagnosed as positive for genital warts during the examination.
  • The Control group was composed of healthy adolescents who admitted for contraceptive counselling.

Exclusion criteria

Exclusion Criteria:

  • Chronical disease including rheumatological diseases, renal failure, diabetes mellitus, hypertension, dyslipidemia, obesity, thyroid dysfunction, cardiopulmonary diseases, malignancy, cerebrovascular diseases, psychiatric and mental disorders, cerebrovascular diseases, inflammatory bowel diseases.
  • Drug administration which may interfere sexual function.
  • Surgical intervention to genital organs.
  • History of pregnancy, delivery, and/or breastfeeding.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Adolescents with genital warts (Study Group)

    The Study group included adolescents who was diagnosed as positive for genital warts during the examination.

    Other: Clinical assessment

  • Healthy adolescents (Control Group)

    The Control group was composed of healthy adolescents who admitted for only contraceptive counselling.

    Other: Clinical assessment

Interventions

  • OtherClinical assessment

    FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.

06

What researchers measure

Primary outcomes

  1. Female Sexual Function Index

    Questionnaire score with minimum and maximum levels of 2.4 and 36 points,respectively. Higher scores mean a better outcome.

    Time frame: Through study completion, an average of 6 months

Secondary outcomes

  1. Arizona Sexual Experiences Scale

    Questionnaire score with minimum and maximum levels of 5 and 30 points,respectively. Higher scores mean a worse outcome.

    Time frame: Through study completion, an average of 6 months

  2. Female Sexual Distress Scale-Revised

    Questionnaire score with minimum and maximum levels of 0 and 50 points,respectively. Higher scores mean a worse outcome.

    Time frame: Through study completion, an average of 6 months

07

Study locations

1 site
  • Ankara City Hospital
    Ankara, 06100, Turkey
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References and documents

Publications

  • Graziottin A, Serafini A. HPV infection in women: psychosexual impact of genital warts and intraepithelial lesions. J Sex Med. 2009 Mar;6(3):633-45. doi: 10.1111/j.1743-6109.2008.01151.x. Epub 2009 Jan 13. PubMed 19170869 ↗
  • McCabe MP, Sharlip ID, Atalla E, Balon R, Fisher AD, Laumann E, Lee SW, Lewis R, Segraves RT. Definitions of Sexual Dysfunctions in Women and Men: A Consensus Statement From the Fourth International Consultation on Sexual Medicine 2015. J Sex Med. 2016 Feb;13(2):135-43. doi: 10.1016/j.jsxm.2015.12.019. PubMed 26953828 ↗
  • McGahuey CA, Gelenberg AJ, Laukes CA, Moreno FA, Delgado PL, McKnight KM, Manber R. The Arizona Sexual Experience Scale (ASEX): reliability and validity. J Sex Marital Ther. 2000 Jan-Mar;26(1):25-40. doi: 10.1080/009262300278623. PubMed 10693114 ↗
  • Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597. PubMed 10782451 ↗
  • Greydanus DE, Matytsina L. Female sexual dysfunction and adolescents. Curr Opin Obstet Gynecol. 2010 Oct;22(5):375-80. doi: 10.1097/GCO.0b013e32833d9418. PubMed 20706119 ↗
  • Derogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27. PubMed 18042215 ↗
  • O'Sullivan LF, Byers ES, Brotto LA, Majerovich JA, Fletcher J. A Longitudinal Study of Problems in Sexual Functioning and Related Sexual Distress Among Middle to Late Adolescents. J Adolesc Health. 2016 Sep;59(3):318-324. doi: 10.1016/j.jadohealth.2016.05.001. Epub 2016 Jun 16. PubMed 27320034 ↗

Individual participant data

Plan to share: No — Data belonging to participants only will be available to any researcher or editorial review board if needed.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04796090
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Esin Merve Erol Koç (Principal Investigator, Ankara City Hospital Bilkent) — Principal investigator
First posted
Mar 12, 2021
Start date
Aug 1, 2020
Primary completion
Feb 1, 2021
Completion
Feb 15, 2021
Last update
Mar 15, 2021

Study contacts

Esin Merve Erol Koç, MD
principal investigator · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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