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Taste Function and Eating Habits in Polycystic Ovary Syndrome

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT04238078
Collaborator
(none)
80
Enrollment
1
Location
6
Actual Duration (Months)
13.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates taste function and eating habits in patients with PCOS compared to healthy women and before and after oral contraceptive use.

Condition or Disease Intervention/Treatment Phase

Detailed Description

The objective of this study is to investigate the taste function and eating habits in patients with PCOS in comparison with healthy women at baseline and after routine use of an oral contraceptive (2mg ethinylestradiol and 0.03mg dienogest) along with general lifestyle advice for three months.

Patients with diagnosis of PCOS (Rotterdam criteria) will be recruited from Hacettepe University outpatient clinics. Along with clinical, hormonal and biochemical evaluation, taste function and eating habit tests will be performed at baseline both in patients and healthy volunteers. These tests will be repeated in women with PCOS after 3 months of oral contraceptive use.

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Investigation of Taste Function and Eating Habits in Women With Polycystic Ovary Syndrome
Actual Study Start Date :
Jan 15, 2020
Actual Primary Completion Date :
Jul 15, 2020
Actual Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Polycystic ovary syndrome

Women with PCOS diagnosed according to Rotterdam criteria

Drug: Contraceptive
Oral contraceptive pill
Other Names:
  • birth control pill

    		•
    Healthy control

    Healthy women without any feature of ovulatory dysfunction or androgen excess

    Outcome Measures

    Primary Outcome Measures

    1. Taste function [Three months]

      Taste function assessed by use of taste strip test

    Secondary Outcome Measures

    1. Eating habits [Three months]

      Eating habits assessed by questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women diagnosed with PCOS (Rotterdam criteria) who will receive oral contraceptive pill for long-term management
    Exclusion Criteria:

    • Any systemic illness

    • Any other medication use

    • Age<18 or >35 years

    • Pregnant or nursing

    • Untreated hypothyroidism or hyperthyroidism

    • Known rhinoplasty or nasal surgery

    • Known defect in smell or taste function

    • Being active smoker.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hacettepe University School of Medicine Ankara Turkey 06100

    Sponsors and Collaborators

    • Hacettepe University

    Investigators

    • Principal Investigator: Bulent Yildiz, Hacettepe University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Okan Bulent Yildiz, Professor of Medicine, Hacettepe University
    ClinicalTrials.gov Identifier:
    NCT04238078
    Other Study ID Numbers:
    • 17697
    First Posted:
    Jan 23, 2020
    Last Update Posted:
    Jun 30, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Contraceptive Agents

    Study Results

    No Results Posted as of Jun 30, 2021