NCT01961180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

2.1 years

First QC Date

July 3, 2013

Last Update Submit

May 6, 2016

Conditions

Polycystic Ovary Syndrome

Keywords

Quality of LifeAdrenal hyper activityGlucose metabolism

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Measured by questionaires

    14 weeks

Secondary Outcomes (1)

  • Level of cortisone in 24 hour urine sample

    June 2013 to October 2015

Other Outcomes (1)

  • Glucose metabolism

    June 2013 to October 2015

Study Arms (2)

active comparator

ACTIVE COMPARATOR

Drug: Cipralex

Drug: Cipralex

placebo comparator

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

CipralexDRUG

the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.

Also known as: Escitalopram
active comparator
PlaceboDRUG

Placebo

placebo comparator

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>25 and \<50
  • Age \< 50
  • PCOS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

DexetimideEscitalopram

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Marianne MD Andersen, sponsor

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, chief physisian

Study Record Dates

First Submitted

July 3, 2013

First Posted

October 11, 2013

Study Start

June 1, 2013

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

May 9, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Locations

DK(1)