NCT04238078

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 15, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

January 19, 2020

Last Update Submit

June 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Taste function

    Taste function assessed by use of taste strip test

    Three months

Secondary Outcomes (1)

  • Eating habits

    Three months

Study Arms (2)

Polycystic ovary syndrome

Women with PCOS diagnosed according to Rotterdam criteria

Drug: Contraceptive

Healthy control

Healthy women without any feature of ovulatory dysfunction or androgen excess

Interventions

Oral contraceptive pill

Also known as: birth control pill
Polycystic ovary syndrome

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with PCOS
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Outpatient clinic

You may qualify if:

  • Women diagnosed with PCOS (Rotterdam criteria) who will receive oral contraceptive pill for long-term management

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University School of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

Related 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. doi: 10.1038/sj.ejcn.1602371. Epub 2006 Jan 25.

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Contraceptive AgentsContraceptives, Oral

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesContraceptive Agents, Female

Study Officials

  • Bulent Yildiz

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 23, 2020

Study Start

January 15, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

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

Locations