The Effect of Cipralex on Quality of Life, Adrenal Activity Glucose Metabolism, Physical and Mental Health in PCOS
- Registration Number
- NCT01961180
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
- BMI >25 and <50
- Age < 50
- PCOS
- Epilepsia
- use of metformin or oral anticonceptives
- pregnancy/breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description placebo comparator Placebo Drug: Placebo active comparator Cipralex Drug: Cipralex
- Primary Outcome Measures
Name Time Method Quality of Life 14 weeks Measured by questionaires
- Secondary Outcome Measures
Name Time Method Level of cortisone in 24 hour urine sample June 2013 to October 2015 Cortisone and cortisone metabolites, measured by 24 hour urine sample.
Trial Locations
- Locations (1)
Department of Endocrinology, Odense University Hospital
🇩🇰Odense, Denmark