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

Odense University Hospital

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo; Drug: Cipralex

Study type: Interventional

Funder types: Other

Identifiers

NCT01961180

24638418

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI >25 and <50
• Age < 50
• PCOS

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

active comparator

Active Comparator group

Description:

Drug: Cipralex

Treatment:

Drug: Cipralex

placebo comparator

Placebo Comparator group

Description:

Drug: Placebo

Treatment:

Drug: Placebo