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

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

Tracking Information

• First Submitted Date: July 3, 2013
• First Posted Date: October 11, 2013
• Last Update Posted Date: May 9, 2016
• Study Start Date: June 2013
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2013)

Quality of Life [ Time Frame: 14 weeks ]

Measured by questionaires

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01961180 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: 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: 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

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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Polycystic Ovary Syndrome

Intervention

• 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

• Active Comparator: active comparator
  Drug: Cipralex
  Intervention: Drug: Cipralex
• Placebo Comparator: placebo comparator
  Drug: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 6, 2016): 42
• Original Estimated Enrollment (submitted: October 10, 2013): 40
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• BMI >25 and <50
• Age < 50
• PCOS

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01961180
• Other Study ID Numbers: 24638418
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Responsible Party: Marianne Andersen, Odense University Hospital
• Study Sponsor: Odense University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marianne MD Andersen, sponsor; Odense University Hospital

• PRS Account: Odense University Hospital
• Verification Date: May 2016