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Endometriosis Patients Undergoing Quinagolide Treatment

Primary Purpose

Hyperprolactinemia, Endometriosis

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

ENDOMETRIAL BIOPSY

About this trial

This is an interventional health services research trial for Hyperprolactinemia focused on measuring Hyperprolactinemia, Endometriosis, laparoscopy, angiogenesis, VEGF

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Hyperprolactinemia
Unexplained infertility
Endometriosis

Sites / Locations

Instituto Valenciano de Infertilidad

Outcomes

Primary Outcome Measures

observation of three month treatment with Quinagolida in endometriosis patients

Secondary Outcome Measures

Full Information

NCT ID

NCT00625950

First Posted

February 20, 2008

Last Updated

January 9, 2009

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

1. Study Identification

Unique Protocol Identification Number

NCT00625950

Brief Title

Endometriosis Patients Undergoing Quinagolide Treatment

Official Title

Effect of Treatment With Agonist Dopaminergics on Endometriosic Lesions.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperprolactinemia, Endometriosis

Keywords

Hyperprolactinemia, Endometriosis, laparoscopy, angiogenesis, VEGF

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

ENDOMETRIAL BIOPSY

Intervention Description

Two routine laparoscopies in period of three months with endometrial biopsy comparative study performed.

Primary Outcome Measure Information:

Title

observation of three month treatment with Quinagolida in endometriosis patients

Time Frame

onset and three months after onset

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hyperprolactinemia Unexplained infertility Endometriosis

Facility Information:

Facility Name

Instituto Valenciano de Infertilidad

City

Valencia

ZIP/Postal Code

46015

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

21055747

Citation

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.

Results Reference

derived

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Endometriosis Patients Undergoing Quinagolide Treatment

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