The Effect of Cipralex on Quality of Life, Adrenal Activi... | NCT01961180

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

NCT01961180

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

May 9, 2016Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Polycystic Ovary Syndrome

Interventions

Cipralex
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jul 3, 2013

First Submission Date that Met QC Criteria

Oct 10, 2013

First Posted Date

Oct 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2016

Last Update Posted Date

May 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marianne Andersen, Professor, chief physisian, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
active comparator	Active Comparator	Drug: Cipralex	Drug: Cipralex
placebo comparator	Placebo Comparator	Drug: Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cipralex	Drug	the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.	active comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of Life	Measured by questionaires	14 weeks

Secondary Outcomes

Measure	Description	Time Frame
Level of cortisone in 24 hour urine sample	Cortisone and cortisone metabolites, measured by 24 hour urine sample.	June 2013 to October 2015

Other Outcomes

Measure	Description	Time Frame
Glucose metabolism	measures bu 3 hour Glucose Tolerance Test, and homeostasis model assessment-insulin resistance(HOMA-IR)	June 2013 to October 2015

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI >25 and <50
Age < 50
PCOS

Exclusion Criteria:

Epilepsia
use of metformin or oral anticonceptives
pregnancy/breastfeeding

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marianne MD Andersen, sponsor	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Odense University Hospital		Odense		5000	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003909	Dexetimide
D000089983	Escitalopram

Ancestor Terms

ID	Term
D010881	Piperidones
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided