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Completed

NCT Number: NCT01961180

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI >25 and <50
  • Age < 50
  • PCOS

Exclusion criteria

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

Treatment and study plan

Cipralex

Drug

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

Other names: Escitalopram

Placebo

Drug

Placebo

Primary outcomes

  1. Quality of Life

    Time frame: 14 weeks

    Measured by questionaires

Secondary outcomes

  1. Level of cortisone in 24 hour urine sample

    Time frame: June 2013 to October 2015

    Cortisone and cortisone metabolites, measured by 24 hour urine sample.

Other outcomes

  1. Glucose metabolism

    Time frame: June 2013 to October 2015

    measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

The Effect of Cipralex in Polycystic Ovary Syndrome

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 11, 2013
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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