NCT04292587

Brief Summary

Hirsutism is defined as the excessive presence of terminal hairs in the androgen-sensitive areas of the female body, and it is one of the frequent reasons for presenting to dermatology outpatient clinics. Hirsutism influences 5% to 10% of women around the world and leads to psychological problems depending on ethnic and socio-cultural factors. It also causes material burden including medicines, cosmetic products and epilation procedures. The differences in the real prevalence of hirsutism in the Turkish population and the hirsutism prevalence and severity between the geographical regions of Turkey are not known. In this study, we aimed to determine the prevalence of hirsutism in women at the reproductive age within Turkey. The geographical regions of Turkey comprise seven regions and and all regions were included in this study. By considering the regions where ethnic differences were high including the east-west-south and north of our country, we aimed to find an answer to the question of whether there were differences in terms of the prevalence and severity of hirsutism among these regions. A comprehensive study aiming to determine the prevalence of hirsutism in Turkey has not been conducted.

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
5,861

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

26 active sites

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

February 3, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

8 months

First QC Date

February 26, 2020

Last Update Submit

March 1, 2020

Conditions

Keywords

Ferriman-Gallwey score, hirsutism, prevalence

Outcome Measures

Primary Outcomes (1)

  • Modified Ferriman-Gallwey Scoring System for Severity of Hirsutism

    In this system, hair growth in nine regions (upper lip, chin, chest, upper back, lower back, upper abdomen, lower abdomen, upper arms and thighs) is graded between 0 and 4. And nine regions are scored between 0 (no terminal hairs) and 4 (excessive presence of terminal hairs). The score above 8 is considered hirsutism.

    1 day (At the time of the examination)

Secondary Outcomes (5)

  • Number of Participants With Concomitant disease status and the risk factors

    1 day (At the time of the examination)

  • Body mass indices of the participants

    1 day (At the time of the examination)

  • The presence and severity of acne in the participants

    1 day (At the time of the examination)

  • The presence and severity of androgenic alopecia in the participants

    1 day (At the time of the examination)

  • Menstrual cycle pattern of the participants

    1 day (At the time of the examination)

Study Arms (2)

Women with hirsutism

Women between the ages of 18-45 with hirsutism

Women without hirsutism

Women between the ages of 18-45 without hirsutism

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

During the study period, female patients aged between 18 and 45, who present to dermatology outpatient clinics, will be examined consecutive until the number of patients designated for each study center is reached.

You may qualify if:

  • Female patients aged between 18 and 45, who presented to the dermatology outpatient clinics for any reason
  • Not being in pregnancy and lactation period
  • Not applying permanent epilation
  • Not using temporary hair reduction methods in the last 4 weeks
  • Not using oral contraceptive, corticosteroid, cyclosporin or spironolactone in the last 3 months

You may not qualify if:

  • Female patients below the age of 18, above 45 and men in any age group
  • Pregnant women and women in lactation period
  • Patients who had permanent epilation
  • Patients who had temporary hair reduction methods in the last 4 weeks
  • Patients taking oral contraceptive, corticosteroid, cyclosporin or spironolactone in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Adana City Training and Research Hospital

Adana, 01358, Turkey (Türkiye)

RECRUITING

School of Medicine, Aksaray University

Aksaray, 68000, Turkey (Türkiye)

RECRUITING

School of Medicine, Ankara Yıldırım Beyazıt University

Ankara, 06010, Turkey (Türkiye)

RECRUITING

School of Medicine, Aydın Adnan Menderes University

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Bitlis Tatvan State Hospital

Bitlis, 13200, Turkey (Türkiye)

RECRUITING

School of Medicine, Uludag University

Bursa, 16285, Turkey (Türkiye)

RECRUITING

University of Health Sciences, Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

RECRUITING

School of Medicine, Trakya University

Edirne, 22030, Turkey (Türkiye)

RECRUITING

School of Medicine, Eskisehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

RECRUITING

School of Medicine, Gaziantep University

Gaziantep, 27310, Turkey (Türkiye)

RECRUITING

School of Medicine, Süleyman Demirel University

Isparta, 32260, Turkey (Türkiye)

RECRUITING

University of Health Sciences, Bakırköy Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

RECRUITING

University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

Istanbul Medeniyet University, Goztepe Research and Training Hospital

Istanbul, 34730, Turkey (Türkiye)

RECRUITING

University of Health Sciences, Umraniye Training and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

School of Medicine,Izmir Katip Celebi University

Izmir, 35620, Turkey (Türkiye)

RECRUITING

School of Medicine,Kahramanmaras Sutcu Imam University

Kahramanmaraş, 46050, Turkey (Türkiye)

RECRUITING

School of Medicine, Kocaeli University

Kocaeli, 41001, Turkey (Türkiye)

RECRUITING

Meram School of Medicine, Necmettin Erbakan University

Konya, 42090, Turkey (Türkiye)

RECRUITING

School of Medicine, Celal Bayar University

Manisa, 45140, Turkey (Türkiye)

RECRUITING

Sanlıurfa Training and Research Hospital

Sanliurfa, 63300, Turkey (Türkiye)

RECRUITING

School of Medicine, Namık Kemal University

Tekirdağ, 59030, Turkey (Türkiye)

RECRUITING

School of Medicine,Tokat Gaziosmanpasa University

Tokat Province, 60030, Turkey (Türkiye)

RECRUITING

School of Medicine,Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

University of Health Sciences, Van Training and Research Hospital

Van, 65100, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Li R, Qiao J, Yang D, Li S, Lu S, Wu X, Wei Z. Epidemiology of hirsutism among women of reproductive age in the community: a simplified scoring system. Eur J Obstet Gynecol Reprod Biol. 2012 Aug;163(2):165-9. doi: 10.1016/j.ejogrb.2012.03.023. Epub 2012 Jun 28.

    PMID: 22748844BACKGROUND
  • Lumezi BG, Berisha VL, Pupovci HL, Goci A, Hajrushi AB. Grading of hirsutism based on the Ferriman-Gallwey scoring system in Kosovar women. Postepy Dermatol Alergol. 2018 Dec;35(6):631-635. doi: 10.5114/ada.2018.77615. Epub 2018 Nov 13.

    PMID: 30618534BACKGROUND
  • Fatemi Naeini F, Najafian J, Jazebi N. Hirsutism and body mass index in a representative sample of Iranian people. ARYA Atheroscler. 2012 Spring;8(1):43-54.

    PMID: 23056100BACKGROUND
  • Carmina E. Prevalence of idiopathic hirsutism. Eur J Endocrinol. 1998 Oct;139(4):421-3. doi: 10.1530/eje.0.1390421.

    PMID: 9820619BACKGROUND

MeSH Terms

Conditions

Hirsutism

Condition Hierarchy (Ancestors)

Hair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesVirilismSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Filiz Cebeci Kahraman, Assoc. Prof.

    University of Health Sciences, Goztepe Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Filiz Cebeci Kahraman, Assoc. Prof.

CONTACT

Sevil Savas Erdogan, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 3, 2020

Study Start

February 3, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations