Adolescent DevelopmentNCT04796090
Genital Wart and Sexuality in Adolescence
An observational study of Adolescent Development and Genital Wart, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Development, Genital Wart, Sexual Dysfunction
- What is being tested?
- Clinical assessment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genital Warts is Related With Sexual Dysfunction and Sexual Distress in Adolescence
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.
- Being tested
- Clinical assessment
- Keywords
- Genital wart, Female sexual dysfunction, Late adolescence, Sexuality related distress
- Medical subject headings
- Condylomata Acuminata, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentOther
FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with genital warts (Study Group) | The Study group included adolescents who was diagnosed as positive for genital warts during the examination. Receives: Other: Clinical assessment | |
| Healthy adolescents (Control Group) | The Control group was composed of healthy adolescents who admitted for only contraceptive counselling. Receives: Other: Clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index
Questionnaire score with minimum and maximum levels of 2.4 and 36 points,respectively. Higher scores mean a better outcome.
Measured: Through study completion, an average of 6 months
Secondary outcomes (2)
Arizona Sexual Experiences Scale
Questionnaire score with minimum and maximum levels of 5 and 30 points,respectively. Higher scores mean a worse outcome.
Measured: Through study completion, an average of 6 months
Female Sexual Distress Scale-Revised
Questionnaire score with minimum and maximum levels of 0 and 50 points,respectively. Higher scores mean a worse outcome.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Aug 2020
- Primary completion1 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Merve Erol Koç, Ankara City Hospital Bilkent
- Investigators
- Esin Merve Erol Koç, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796090
- Sponsor's protocol ID
- E1-20-1000
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data belonging to participants only will be available to any researcher or editorial review board if needed.
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 19170869McCabe 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 26953828McGahuey 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 10693114Rosen 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 10782451Greydanus DE, Matytsina L. Female sexual dysfunction and adolescents. Curr Opin Obstet Gynecol. 2010 Oct;22(5):375-80. doi: 10.1097/GCO.0b013e32833d9418.
PubMed 20706119Derogatis 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 18042215O'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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genital Warts is Related With Sexual Dysfunction and Sexual Distress in Adolescence
- ClinicalTrials.gov ID
- NCT04796090
- Acronym / sponsor ID
- E1-20-1000
- Keywords
- Genital wart, Female sexual dysfunction, Late adolescence, Sexuality related distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with genital warts (Study Group) | – | Other: Clinical assessmentThe Study group included adolescents who was diagnosed as positive for genital warts during the examination. |
| Healthy adolescents (Control Group) | – | Other: Clinical assessmentThe Control group was composed of healthy adolescents who admitted for only contraceptive counselling. |
Who may qualify
- Ages
- 17 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentFSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts. | Other | Adolescents with genital warts (Study Group), Healthy adolescents (Control Group) |
Primary outcome
Female Sexual Function Index
Time frame: Through study completion, an average of 6 months
Questionnaire score with minimum and maximum levels of 2.4 and 36 points,respectively. Higher scores mean a better outcome.
2 secondary outcomes
Arizona Sexual Experiences Scale
Time frame: Through study completion, an average of 6 months
Female Sexual Distress Scale-Revised
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Results publication: PubMed 19170869Graziottin 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.
- Results publication: PubMed 26953828McCabe 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.
- Results publication: PubMed 10693114McGahuey 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.
- Results publication: PubMed 10782451Rosen 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.
- Results publication: PubMed 20706119Greydanus DE, Matytsina L. Female sexual dysfunction and adolescents. Curr Opin Obstet Gynecol. 2010 Oct;22(5):375-80. doi: 10.1097/GCO.0b013e32833d9418.
- Results publication: PubMed 18042215Derogatis 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.
- Results publication: PubMed 27320034O'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.
- Individual participant dataSharing planned: No. Data belonging to participants only will be available to any researcher or editorial review board if needed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esin Merve Erol Koç, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Development and Genital Wart, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04796090, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.