AzTrials
AzTrials

Polycystic Ovary SyndromeNCT01319162

Prevalence of Polycystic Ovary Syndrome (PCOS) in Obese Premenopausal Women

An observational study of Polycystic Ovary Syndrome, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese and obesity is closely linked to the development of PCOS. Although it is well established that obesity increases the severity of the clinical features of PCOS, data regarding the prevalence of PCOS in obese women and the change… Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Weight reduction regimen
How many people
300 participants
Where
1 siteSweden
Study dates
30 Mar 2011to 11 Jan 2017
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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: All obese women between 18 and 50 years referred to a weight reduction treatment program at the Sahlgrenska Obesity Center at Sahlgrenska University hospital will, after oral and written informed consent, be screened for the diagnosis of PCOS according to NIH or Rotterdam diagnostic criteria depending on the availability of ultrasonography.

Who may be able to join

  • PCOS diagnostic criteria should be the presence of both clinical and/or biochemical hyperandrogenism and/or oligo-/amenorrhea and/or polycystic ovaries (PCO).

Who cannot join

  • Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
  • Pregnancy or breastfeeding the last 6 months.
  • Any sign of climacteric symptoms.
  • Language barrier or disabled person with reduced ability to understand information.
  • Oral contraceptives and insulin sensitizing agents is commonly used among women with PCOS since it may interfere with hormone profile. As the prevalence of PCOS can be assumed to be increased among women using oral contraceptives and insulin sensitizing agents, they are included but analyzed separately.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska Obesity Center at Sahlgrenska University hospital

    Gothenburg, 41345

Other trials in Sweden

About this study

Official title: To Estimate the Prevalence of PCOS in Obese Premenopausal Women and Elucidate How They Respond to a Weight Reduction Treatment Program

Between 40% and 85% of women with Polycystic Ovary Syndrome (PCOS) are overweight or obese and obesity is closely linked to the development of PCOS. Although it is well established that obesity increases the severity of the clinical features of PCOS, data regarding the prevalence of PCOS in obese women and the change in body weight in women with PCOS over time are scares. In a prevalence study it was investigated whether obesity increases the risk of PCOS in the general population and they demonstrated that the prevalence rate of PCOS in underweight, normal-weight, overweight, and obese women were 8.2, 9.8, 9.9, and 9.0%, respectively, similar to that observed in the general population. These results suggest that the risk of PCOS is only minimally increased with obesity. On the other hand, in a Spanish prevalence study among overweight and obese subjects, they demonstrated a 28.3% prevalence of PCOS, which is markedly higher compared with the 5.5% prevalence of PCOS in lean women in Spain.

First the investigators aim to estimate the prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden. Secondly, to elucidate whether women diagnosed with PCOS respond to standard weight reduction regime to the same extent as women without PCOS.

Being tested
Weight reduction regimen
Keywords
PCOS
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.

  • Weight reduction regimenOther

    The dietary intervention begins with a 12-weeks VLCD/LCD period. The diet comprise of 3 to 5 portions liquid diet with a daily energy intake of 450-800 kcal. In addition, patients will be encouraged to drink 1,5-2L daily of non-caloric beverages (<6 kcal/100 ml). All patients will have scheduled nurse visits at week 0 (baseline), 2, 5, 8, and 12. At these visits general well-being and body weight will be monitored. The patient will also be given support and counselling to enhance compliance to the VLCD/LCD diet.

Study groups in NCT01319162
Study groupRoleWhat they receive
Women with PCOSAll obese women between 18 and 50 years diagnosed with PCOS referred to a weight reduction treatment program at the Sahlgrenska Obesity Center at Sahlgrenska University hospital
Receives: Other: Weight reduction regimen
Women without PCOSAll obese women between 18 and 50 years not diagnosed with PCOS referred to a weight reduction treatment program at the Sahlgrenska Obesity Center at Sahlgrenska University hospital
Receives: Other: Weight reduction regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden.

    Screening for PCOS among obese women includes menstrual history, clinical and biochemical signs of hyperandrogenism and polycystic ovaries on ultrasound measure in women with one of signs included in the diagnosis of the syndrome.

    Measured: Within one month after first visit

Secondary outcomes (5)

  1. Response to weight reduction regime among obese women with and without PCOS

    Measured: One year after inclusion

  2. Food frequency

    Measured: Within one month after measure

  3. Health Related Quality of Life

    Measured: Screening and one year later

  4. Symptoms of anxiety and depression

    Measured: Screening and after one year

  5. Changes in sex steroids and other related hormones

    Measured: Screening and after 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2011 (estimated)
  2. Study start30 Mar 2011
  3. Primary completion11 Jan 2017
  4. Study completion11 Jan 2017

Resources

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
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01319162
Sponsor's protocol ID
Prevalence-PCOS-Obesity
Status last verified
Mar 2017
First submitted
18 Mar 2011
Last updated
16 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Samad M, Ek J, Kataoka J, Lindgren E, Ohlsson C, Wernstedt Asterholm I, Stener-Victorin E, Benrick A. Hypoadiponectinemia does not enhance anxiety-like behaviour in a lean PCOS-like mouse model. Sci Rep. 2026 Sep 3;16(1):27688. doi: 10.1038/s41598-026-69143-9.

    PubMed 42693220

  • Kataoka J, Olsson M, Lindgren E, Larsson I, Schmidt J, Benrick A, Stener-Victorin E. Effects of weight loss intervention on anxiety, depression and quality of life in women with severe obesity and polycystic ovary syndrome. Sci Rep. 2024 Jun 12;14(1):13495. doi: 10.1038/s41598-024-63166-w.

    PubMed 38866860

  • Kataoka J, Stener-Victorin E, Schmidt J, Larsson I. A prospective 12-month structured weight loss intervention in women with severe obesity and polycystic ovary syndrome: Impact of weight loss on eating behaviors. Acta Obstet Gynecol Scand. 2024 Aug;103(8):1615-1624. doi: 10.1111/aogs.14867. Epub 2024 May 8.

    PubMed 38717931

  • Kataoka J, Larsson I, Lindgren E, Kindstrand LO, Schmidt J, Stener-Victorin E. Circulating Anti-Mullerian hormone in a cohort-study of women with severe obesity with and without polycystic ovary syndrome and the effect of a one-year weight loss intervention. Reprod Biol Endocrinol. 2022 Oct 29;20(1):153. doi: 10.1186/s12958-022-01022-0.

    PubMed 36309748

  • Kataoka J, Larsson I, Bjorkman S, Eliasson B, Schmidt J, Stener-Victorin E. Prevalence of polycystic ovary syndrome in women with severe obesity - Effects of a structured weight loss programme. Clin Endocrinol (Oxf). 2019 Dec;91(6):750-758. doi: 10.1111/cen.14098. Epub 2019 Oct 1.

    PubMed 31529511

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome, run by Göteborg University at 1 site in Sweden.

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 5 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 16 Mar 2017. 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 Sweden. 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?

Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden. (time frame: Within one month after first visit). 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 NCT01319162, which also lists 5 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 16 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in