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
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|
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 (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: active comparator
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
- Quality of Life [ Time Frame: 14 weeks ]Measured by questionaires
- 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.
- Glucose metabolism [ Time Frame: June 2013 to October 2015 ]measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)
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
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Marianne MD Andersen, sponsor||Odense University Hospital|