Study Results
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Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2013-08-31
2017-10-31
Brief Summary
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PCOS is a common endocrine disorder characterized by adrenal and ovarian hyperandrogenaemia, anovulation and insulin resistance. The pathogenesis of PCOS may be described by a vicious cycle involving insulin resistance which stimulates ovarian and adrenal hyper androgenaemia and leads to abdominal obesity, causing increased risk for diabetes and cardiovascular disease. Adrenal hyperactivity is associated with depression. Antidepressive medicine may normalize pituitary-adrenal activity and in animal studies antidepressive medicine improved adrenal hyperactivity and normalized insulin sensitivity.
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Detailed Description
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Hypothesis Participants with PCOS have increased hypothalamic-pituitary-adrenal activity compared to healthy women. Antidepressive treatment improves quality of life, cortisone and glucose turnover.
Design A randomized controlled study in 40 PCOS patients who are treated with cipralex or placebo for 12 weeks. Before and after the treatment period the patients have a physical examination, a whole body dexa scan and fasting blood samples. Hypothalamic-pituitary-adrenal is measured by 24 hour samples of cortisone metabolites, 60 minutes ACTH test with basal and stimulated measurement of cortisone and 17-hydroxyprogesterone. Glucose metabolism is examined by oral glucose tolerance test. Biopsies of muscle and fat are also performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cipralex
Escitalopram 20 mg x 1 for 12 weeks
Placebo
Placebo
Placebo 20 mg x 1 for 12 weeks
Escitalopram 20 mg
Antidepressant
Interventions
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Escitalopram 20 mg
Antidepressant
Placebo
Eligibility Criteria
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Inclusion Criteria
* Age 18-45 years
* Two of the following 1: an/oligomenorhea, 2: Hirsutism or hyper androgenaemia, 3: PCO in trans vaginal ultrasound
* Other diagnoses excluded
Exclusion Criteria
* Diabetes
* Eating disorder
* Psychiatric disorder
* Usage of oral anticonceptives or metformin
* Pregnancy or planned pregnancy in the treatment period
* Non-caucasian
* Epilepsy
* Allergy to the medicine
18 Years
45 Years
FEMALE
Yes
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Marianne Andersen
Clinical professor, MD
Principal Investigators
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Marianne Andersen, DMSci
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense Universitetshospital
Odense, , Denmark
Countries
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Other Identifiers
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herbert4
Identifier Type: -
Identifier Source: org_study_id
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