NCT04796090

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
Last Updated

March 15, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 10, 2021

Last Update Submit

March 11, 2021

Conditions

Keywords

Genital wartFemale sexual dysfunctionLate adolescenceSexuality related distress

Outcome Measures

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.

    Through study completion, an average of 6 months

Secondary Outcomes (2)

  • Arizona Sexual Experiences Scale

    Through study completion, an average of 6 months

  • Female Sexual Distress Scale-Revised

    Through study completion, an average of 6 months

Study Arms (2)

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

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

Adolescents with genital warts (Study Group)Healthy adolescents (Control Group)

Eligibility Criteria

Age17 Years - 21 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is aimed to elucidate female adolescents' sexual functions.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • Greydanus DE, Matytsina L. Female sexual dysfunction and adolescents. Curr Opin Obstet Gynecol. 2010 Oct;22(5):375-80. doi: 10.1097/GCO.0b013e32833d9418.

  • 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.

  • 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.

MeSH Terms

Conditions

Condylomata AcuminataSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Papillomavirus InfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesWartsSkin Diseases, ViralTumor Virus InfectionsGenital DiseasesUrogenital DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Esin Merve Erol Koç, MD

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 12, 2021

Study Start

August 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 15, 2021

Last Updated

March 15, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Data belonging to participants only will be available to any researcher or editorial review board if needed.

Locations