Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE October 11, 2013
Last Update Posted Date May 9, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
Quality of Life [ Time Frame: 14 weeks ]
Measured by questionaires
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01961180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 10, 2013)
Glucose metabolism [ Time Frame: June 2013 to October 2015 ]
measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS
Official Title  ICMJE The Effect of Cipralex in Polycystic Ovary Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE
  • Drug: Cipralex
    the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
    Other Name: Escitalopram
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: active comparator
    Drug: Cipralex
    Intervention: Drug: Cipralex
  • Placebo Comparator: placebo comparator
    Drug: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2016)
42
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2013)
40
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Epilepsia
  • use of metformin or oral anticonceptives
  • pregnancy/breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01961180
Other Study ID Numbers  ICMJE 24638418
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Marianne Andersen, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marianne MD Andersen, sponsor Odense University Hospital
PRS Account Odense University Hospital
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP