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

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Weight reduction regimen

• Registration Number: NCT01319162
• Lead Sponsor: Göteborg University

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Study Start: 2011-03-30
• Primary Completion: 2017-01-11
• Study Completion: 2017-01-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

1. Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
2. Pregnancy or breastfeeding the last 6 months.
3. Any sign of climacteric symptoms.
4. Language barrier or disabled person with reduced ability to understand information.
5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with PCOS	Weight reduction regimen	All 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
Women without PCOS	Weight reduction regimen	All 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

Primary Outcome Measures

Name	Time	Method
Prevalence/probability of PCOS among obese, premenopausal women (between 18 and 50 years) with no symptoms of classic menopausal symptoms in Sweden.	Within one month after first visit	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.

Secondary Outcome Measures

Name	Time	Method
Response to weight reduction regime among obese women with and without PCOS	One year after inclusion
Food frequency	Within one month after measure
Health Related Quality of Life	Screening and one year later
Symptoms of anxiety and depression	Screening and after one year
Changes in sex steroids and other related hormones	Screening and after 1 year

Trial Locations

Locations (1)

Sahlgrenska Obesity Center at Sahlgrenska University hospital; 🇸🇪 Göteborg, Sweden