Polycystic Ovary SyndromeNCT04238078
Taste Function and Eating Habits in Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Contraceptive
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2020to 15 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Outpatient clinic
Who may be able to join
- Women diagnosed with PCOS (Rotterdam criteria) who will receive oral contraceptive pill for long-term management
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University School of Medicine
Ankara, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Contraceptive
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContraceptiveDrug
Also called birth control pill
Oral contraceptive pill
| Study group | Role | What they receive |
|---|---|---|
| Polycystic ovary syndrome | Women with PCOS diagnosed according to Rotterdam criteria Receives: Drug: Contraceptive | |
| Healthy control | Healthy women without any feature of ovulatory dysfunction or androgen excess |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste function
Taste function assessed by use of taste strip test
Measured: Three months
Secondary outcomes (1)
Eating habits
Eating habits assessed by questionnaire
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start15 Jan 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Okan Bulent Yildiz, Hacettepe University
- Investigators
- Bulent Yildiz, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238078
- Sponsor's protocol ID
- 17697
- Status last verified
- Jun 2021
- First submitted
- 19 Jan 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data generated during the study will be available from the principal investigator on reasonable request
Publications
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.
PubMed 16435003Wolf 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.
PubMed 26633243
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Taste Function and Eating Habits in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04238078
- Acronym / sponsor ID
- 17697
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates taste function and eating habits in patients with PCOS compared to healthy women and before and after oral contraceptive use.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polycystic ovary syndrome | – | Drug: ContraceptiveWomen with PCOS diagnosed according to Rotterdam criteria |
| Healthy control | – | –Healthy women without any feature of ovulatory dysfunction or androgen excess |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Outpatient clinic
Key inclusion criteria (1 listed)
- Women diagnosed with PCOS (Rotterdam criteria) who will receive oral contraceptive pill for long-term management
Key exclusion criteria (8 listed)
- Any systemic illness
- Any other medication use
- Age<18 or >35 years
- Pregnant or nursing
- Untreated hypothyroidism or hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ContraceptiveAlso: birth control pillOral contraceptive pill | Drug | Polycystic ovary syndrome |
Primary outcome
Taste function
Time frame: Three months
Taste function assessed by use of taste strip test
1 secondary outcome
Eating habits
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Results publication: PubMed 16435003Simchen 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.
- Results publication: PubMed 26633243Wolf 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.
- Individual participant dataSharing planned: No. Data generated during the study will be available from the principal investigator on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bulent Yildiz principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taste function (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238078, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.