Genital Diseases, FemaleNCT06134596
Correlation of Clitoral Hood and Labia Minora Measurements and Female Genital Self Image Scale (FGSIS) Scores in Women
An observational study of Genital Diseases, Female and Vulva, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the relationship between women's labium minora and clitoral hood measurements and Female Genital Self Image Scale (FGSIS) scores. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genital Diseases, Female, Vulva
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Mar 2024
- How long will I take part?
- 2 Months
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who apply for outpatient gynecological control, are between the ages of 18-45, are sexually active, do not have additional endocrinological or malignant diseases, and are not pregnant or in menopause.
Who may be able to join
- Women who apply for outpatient gynecological control, are between the ages of 18-45, are sexually active, do not have additional endocrinological or malignant diseases, and are not pregnant or in menopause.
Who cannot join
- Those who are not sexually active, have varying degrees of pelvic organ prolapse or urinary incontinence, have a malignancy, or have an endocrinological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bagcilar Teaching and Research Hospital
Istanbul, Bagcilar, 34200
Evrim Ebru Kovalak, MD, +905324628989, evrimebru@yahoo.com
About this study
To evaluate the relationship between women's labium minora and clitoral hood measurements and Female Genital Self Image Scale (FGSIS) scores.
Read the detailed description
The main purpose of our study is to measure the labium minora and clitoral hood in women who apply to our clinic with gynecological disorders, evaluate them with FGSIS (Female Genital Self Image Scale) scores, and look at the relationship between genital area perception and labium minora and clitoral hood dimensions.
- Conditions
- Genital Diseases, Female, Vulva
- Keywords
- Genital diseases, vulva
- Medical subject headings
- Genital Diseases, Female, Genital Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of genital measurement with genital perception
Since the genital aesthetic trend is very popular today, it is important to understand the importance of labia minora and clitoral hood measurements in female genital perception.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genital Diseases, FemaleStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Evrim Ebru Kovalak, Bagcilar Training and Research Hospital
- Investigators
- Evrim Ebru Kovalak, MD, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134596
- Sponsor's protocol ID
- 2023-06-06
- Status last verified
- Nov 2023
- First submitted
- 11 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Widschwendter A, Riedl D, Freidhager K, Abdel Azim S, Jerabek-Klestil S, D'Costa E, Fessler S, Ciresa-Konig A, Marth C, Bottcher B. Perception of Labial Size and Objective Measurements-Is There a Correlation? A Cross-Sectional Study in a Cohort Not Seeking Labiaplasty. J Sex Med. 2020 Mar;17(3):461-469. doi: 10.1016/j.jsxm.2019.11.272. Epub 2020 Jan 7.
PubMed 31918983Kurtoglu N, Kovalak EE, Hayirlioglu N, Ilhan C, Guraslan H. The Relation Between Female Genital Perception and Genital Measurements: Does Size Matter? Int Urogynecol J. 2026 Apr;37(4):885-891. doi: 10.1007/s00192-025-06321-9. Epub 2025 Oct 23.
PubMed 41131354
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Clitoral Hood and Labia Minora Measurements and Female Genital Self Image Scale (FGSIS) Scores in Women
- ClinicalTrials.gov ID
- NCT06134596
- Acronym / sponsor ID
- 2023-06-06
- Conditions
- Genital Diseases, Female, Vulva
- Keywords
- Genital diseases, vulva
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
To evaluate the relationship between women's labium minora and clitoral hood measurements and Female Genital Self Image Scale (FGSIS) scores.
Detailed description
The main purpose of our study is to measure the labium minora and clitoral hood in women who apply to our clinic with gynecological disorders, evaluate them with FGSIS (Female Genital Self Image Scale) scores, and look at the relationship between genital area perception and labium minora and clitoral hood dimensions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who apply for outpatient gynecological control, are between the ages of 18-45, are sexually active, do not have additional endocrinological or malignant diseases, and are not pregnant or in menopause.
Key inclusion criteria (1 listed)
- Women who apply for outpatient gynecological control, are between the ages of 18-45, are sexually active, do not have additional endocrinological or malignant diseases, and are not pregnant or in menopause.
Key exclusion criteria (1 listed)
- Those who are not sexually active, have varying degrees of pelvic organ prolapse or urinary incontinence, have a malignancy, or have an endocrinological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of genital measurement with genital perception
Time frame: 2 months
Since the genital aesthetic trend is very popular today, it is important to understand the importance of labia minora and clitoral hood measurements in female genital perception.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publication: PubMed 31918983Widschwendter A, Riedl D, Freidhager K, Abdel Azim S, Jerabek-Klestil S, D'Costa E, Fessler S, Ciresa-Konig A, Marth C, Bottcher B. Perception of Labial Size and Objective Measurements-Is There a Correlation? A Cross-Sectional Study in a Cohort Not Seeking Labiaplasty. J Sex Med. 2020 Mar;17(3):461-469. doi: 10.1016/j.jsxm.2019.11.272. Epub 2020 Jan 7.
- Derived from this study: PubMed 41131354Kurtoglu N, Kovalak EE, Hayirlioglu N, Ilhan C, Guraslan H. The Relation Between Female Genital Perception and Genital Measurements: Does Size Matter? Int Urogynecol J. 2026 Apr;37(4):885-891. doi: 10.1007/s00192-025-06321-9. Epub 2025 Oct 23.
- Individual participant dataSharing planned: Undecided
Related trials for Genital Diseases, Female
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Vulvar Cancer
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Evrim Ebru Kovalak, MD principal investigator
Bagcilar Training and Research Hospital
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 Genital Diseases, Female and Vulva, run by Bagcilar Training and Research Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evrim Ebru Kovalak, MD (905324628989, evrimebru@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of genital measurement with genital perception (time frame: 2 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 NCT06134596, which also lists 2 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 18 Nov 2023.