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


N/A
18 Years
50 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Within one month after first visit

Safety Issue:

No

Authority:

Sweden: Regionala etikprövningsnämnden

Study ID:

Prevalence-PCOS-Obesity

NCT ID:

NCT01319162

Start Date:

March 2011

Completion Date:

June 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Polycystic Ovary Syndrome

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