The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS
NCT ID: NCT01961180
Last Updated: 2016-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2013-06-30
2015-10-31
Brief Summary
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Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.
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Detailed Description
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PCOS is characterized by menstrual deregulation, high testosterone, mail hair growth and increased stress hormones from the adrenals. Furthermore there are changes similar to those seen in diabetes.
Cipralex is known to decrease stress hormones. But no investigations are on the effect of cipralex on PCOS, or how the increased stress hormones affect the PCOS condition.
We will examine 2x20 women with PCOS. They will be randomized to Cipralex or placebo. Treatment duration is 12 weeks.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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active comparator
Drug: Cipralex
Cipralex
the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
placebo comparator
Drug: Placebo
Placebo
Placebo
Interventions
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Cipralex
the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \< 50
* PCOS
Exclusion Criteria
* use of metformin or oral anticonceptives
* pregnancy/breastfeeding
18 Years
50 Years
FEMALE
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Marianne Andersen
Professor, chief physisian
Principal Investigators
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Marianne MD Andersen, sponsor
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Department of Endocrinology, Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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24638418
Identifier Type: -
Identifier Source: org_study_id
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