Taste Function and Eating Habits in Polycystic Ovary Syndrome

June 26, 2021 updated by: Okan Bulent Yildiz, Hacettepe University

Investigation of Taste Function and Eating Habits in Women With Polycystic Ovary Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Outpatient clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taste function
Time Frame: Three months
Taste function assessed by use of taste strip test
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating habits
Time Frame: Three months
Eating habits assessed by questionnaire
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Bulent Yildiz, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2020

Primary Completion (ACTUAL)

July 15, 2020

Study Completion (ACTUAL)

July 15, 2020

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

January 19, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 26, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17697

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data generated during the study will be available from the principal investigator on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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