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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04238078
Other study ID # 17697
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2020
Est. completion date July 15, 2020

Study information

Verified date June 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Contraceptive
Oral contraceptive pill

Locations

Country Name City State
Turkey Hacettepe University School of Medicine Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Simchen U, Koebnick C, Hoyer S, Issanchou S, Zunft HJ. Odour and taste sensitivity is associated with body weight and extent of misreporting of body weight. Eur J Clin Nutr. 2006 Jun;60(6):698-705. Epub 2006 Jan 25. — View Citation

Wolf A, Varga L, Wittibschlager L, Renner B, Mueller CA. A self-administered test of taste function using "Taste Strips". Int Forum Allergy Rhinol. 2016 Apr;6(4):362-6. doi: 10.1002/alr.21681. Epub 2015 Dec 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Taste function Taste function assessed by use of taste strip test Three months
Secondary Eating habits Eating habits assessed by questionnaire Three months
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