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

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ClinicalTrials.gov Identifier: NCT01961180
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
Marianne Andersen, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Cipralex Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Cipralex in Polycystic Ovary Syndrome
Study Start Date : June 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015


Arm Intervention/treatment
Active Comparator: active comparator
Drug: Cipralex
Drug: Cipralex
the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
Other Name: Escitalopram

Placebo Comparator: placebo comparator
Drug: Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 14 weeks ]
    Measured by questionaires


Secondary Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961180


Locations
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Denmark
Department of Endocrinology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Marianne MD Andersen, sponsor Odense University Hospital

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Responsible Party: Marianne Andersen, Professor, chief physisian, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01961180     History of Changes
Other Study ID Numbers: 24638418
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Marianne Andersen, Odense University Hospital:
Quality of Life
Adrenal hyper activity
Glucose metabolism

Additional relevant MeSH terms:
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Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin Agents
Antidepressive Agents, Second-Generation