NCT01961180

The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS

The Effect of Cipralex in Polycystic Ovary Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Cipralex	the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
DRUG	Placebo	Placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-07-01
• Completion: 2015-10-01
• First posted: 2013-10-11
• Last updated: 2016-05-09

Locations

1 site across 1 country: Denmark