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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Cipralex
Placebo
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Quality of Life, Adrenal hyper activity, Glucose metabolism

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Endocrinology, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active comparator

placebo comparator

Arm Description

Drug: Cipralex

Drug: Placebo

Outcomes

Primary Outcome Measures

Quality of Life
Measured by questionaires

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2013
Last Updated
May 6, 2016
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01961180
Brief Title
The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS
Official Title
The Effect of Cipralex in Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Quality of Life, Adrenal hyper activity, Glucose metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active comparator
Arm Type
Active Comparator
Arm Description
Drug: Cipralex
Arm Title
placebo comparator
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo
Intervention Type
Drug
Intervention Name(s)
Cipralex
Other Intervention Name(s)
Escitalopram
Intervention Description
the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Quality of Life
Description
Measured by questionaires
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Level of cortisone in 24 hour urine sample
Description
Cortisone and cortisone metabolites, measured by 24 hour urine sample.
Time Frame
June 2013 to October 2015
Other Pre-specified Outcome Measures:
Title
Glucose metabolism
Description
measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)
Time Frame
June 2013 to October 2015

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI >25 and <50 Age < 50 PCOS Exclusion Criteria: Epilepsia use of metformin or oral anticonceptives pregnancy/breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne MD Andersen, sponsor
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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