NCT06134596

Brief Summary

To evaluate the relationship between women's labium minora and clitoral hood measurements and Female Genital Self Image Scale (FGSIS) scores.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 11, 2023

Last Update Submit

November 11, 2023

Conditions

Keywords

Genital diseases, vulva

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Those who are not sexually active, have varying degrees of pelvic organ prolapse or urinary incontinence, have a malignancy, or have an endocrinological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Teaching and Research Hospital

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Genital Diseases, FemaleGenital Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Evrim Ebru Kovalak, MD

    Bagcilar Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Evrim Ebru Kovalak, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

November 11, 2023

First Posted

November 18, 2023

Study Start

November 1, 2023

Primary Completion

December 31, 2023

Study Completion

March 1, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations