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

O

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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