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

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Effect of Cipralex in Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961180
• Other study ID #: 24638418
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2013
• Last updated: May 6, 2016
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: May 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI >25 and <50

• Age < 50

• PCOS

Exclusion Criteria:

• Epilepsia

• use of metformin or oral anticonceptives

• pregnancy/breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Cipralex
the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
• Placebo
Placebo

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glucose metabolism	measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)	June 2013 to October 2015	No
Primary	Quality of Life	Measured by questionaires	14 weeks	No
Secondary	Level of cortisone in 24 hour urine sample	Cortisone and cortisone metabolites, measured by 24 hour urine sample.	June 2013 to October 2015	No