Endometriosis Patients Undergoing Quinagolide Treatment | NCT00625950

Studies
Endometriosis Patients Undergoing Quinagolide Treatment

NCT00625950

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Completed

Last Update Posted

Jan 12, 2009Estimated

Enrollment

5Estimated

Phase

Phase 4

Conditions

Hyperprolactinemia
Endometriosis

Interventions

ENDOMETRIAL BIOPSY

Countries

Spain

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

Jan 2009

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

Feb 2008

Primary Completion Date

Apr 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Feb 28, 2008

First Posted Date

Feb 29, 2008Estimated

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

Jan 9, 2009

Last Update Posted Date

Jan 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Dopamine agonists, such as quinagolide, are able to act on the VEGFR-2 blocking antibodies, diminishing Vascular Endothelial Growth Factor effect on angiogenesis in human endometriotic lesions.

Detailed Description

Not provided

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

5Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENDOMETRIAL BIOPSY	Procedure	Two routine laparoscopies in period of three months with endometrial biopsy comparative study performed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
observation of three month treatment with Quinagolida in endometriosis patients		onset and three months after onset

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hyperprolactinemia
Unexplained infertility
Endometriosis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Valenciano de Infertilidad		Valencia	Valencia	46015	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21055747	Derived	Gomez R, Abad A, Delgado F, Tamarit S, Simon C, Pellicer A. Effects of hyperprolactinemia treatment with the dopamine agonist quinagolide on endometriotic lesions in patients with endometriosis-associated hyperprolactinemia. Fertil Steril. 2011 Mar 1;95(3):882-8.e1. doi: 10.1016/j.fertnstert.2010.10.024. Epub 2010 Nov 5.

ID	Term
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases

ID	Term
D006966	Hyperprolactinemia
D004715	Endometriosis