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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01961180

Enrollment

Registered

2013-10-11

Start date

2013-06-30

Completion date

2015-10-31

Last updated

2016-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Quality of Life, Adrenal hyper activity, Glucose metabolism

Brief 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.

Interventions

DRUGCipralex

the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* BMI \>25 and \<50 * Age \< 50 * PCOS

Exclusion criteria

* Epilepsia * use of metformin or oral anticonceptives * pregnancy/breastfeeding

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	14 weeks	Measured by questionaires

Secondary

Measure	Time frame	Description
Level of cortisone in 24 hour urine sample	June 2013 to October 2015	Cortisone and cortisone metabolites, measured by 24 hour urine sample.

Other

Measure	Time frame	Description
Glucose metabolism	June 2013 to October 2015	measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026