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Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies


N/A
18 Years
37 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

Polycystic Ovary Syndrome (PCOS) - The Female Metabolic Syndrome Genes And Processes In The Aetiology And Pathogenesis Of PCOS And Identification Of New Treatment Strategies


Primary outcome: Changes in androgen concentrations and menstrual pattern

Secondary outcome: changes in sympathetic nerve activity, uterus peristalsis, ovarian
morphology, adipose tissue related variables, insulin sensitivity, coagulation factors and
health related quality of life and symptoms of anxiety and depression.


Inclusion Criteria:



- To get the diagnosis polycystic ovary syndrome (PCOS), ultrasonography should reveal
at least 1 ovary with PCO according to the Rotterdam diagnostic criteria as well as
one of the following two symptoms:

1. Anovulation/oligoovulation defined as ≥ 35 days during the last year

2. Clinical signs of hyperandrogenism (hirsutism, acne)

Exclusion Criteria:

- Cardiovascular disease

- Diabetes mellitus

- Other endocrine disease (congenital adrenal hyperplasia, androgen producing tumour,
Cushing's syndrome)

- Estrogen/gestagen treatment during the last 3 months

- Breast-feeding the last 6 months

- Antiandrogen treatment the last 3 months

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment

Outcome Measure:

To measure if physical exercise and electro-acupuncture restores endocrine, neuroendocrine, metabolic and immunological disturbances related to sympathetic nerve activity as well as psychological distress and improve quality of life in women with PCOS.

Outcome Time Frame:

One year

Principal Investigator

Elisabet Stener-Victorin, Prof, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sahlgrenska Academy, Göteborg University

Authority:

Sweden: The National Board of Health and Welfare

Study ID:

VGFOUREG-7861

NCT ID:

NCT00484705

Start Date:

October 2005

Completion Date:

October 2008

Related Keywords:

  • Polycystic Ovary Syndrome
  • Androgens
  • Menstrual pattern
  • Insulin resistance
  • Adipocytes
  • Obesity
  • Stress
  • Muscle sympathetic nerve activity
  • Psychological distress and quality of life
  • Polycystic Ovary Syndrome

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