A Phase 4 interventional study of Cipralex and Placebo in Polycystic Ovary Syndrome, sponsored by Odense University Hospital. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-05-09.
Sponsored by Odense University Hospital · Phase 4, Interventional, and Treatment
Objectives: To investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).
Treatment: 2x20 women for 12 weeks. Design: Double blinded, randomized, placebo controlled.
We want to investigate the effect of Cipralex versus placebo on stress hormones, glucose metabolism, physical and mental health and quality of life in polycystic ovary syndrome(PCOS).
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 42 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Cipralex
Drug: Cipralex
Drug: Placebo
Drug: Placebo
the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
Also known as: Escitalopram
Placebo
Quality of Life
Measured by questionaires
Time frame: 14 weeks
Level of cortisone in 24 hour urine sample
Cortisone and cortisone metabolites, measured by 24 hour urine sample.
Time frame: June 2013 to October 2015
Glucose metabolism
measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)
Time frame: June 2013 to October 2015
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Odense University Hospital