NCT00625950

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2008

Shorter than P25 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

February 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

2 months

First QC Date

February 20, 2008

Last Update Submit

January 9, 2009

Conditions

HyperprolactinemiaEndometriosis

Keywords

HyperprolactinemiaEndometriosislaparoscopyangiogenesis, VEGF

Outcome Measures

Primary Outcomes (1)

  • observation of three month treatment with Quinagolida in endometriosis patients

    onset and three months after onset

Interventions

ENDOMETRIAL BIOPSYPROCEDURE

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

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hyperprolactinemia
  • Unexplained infertility
  • Endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de Infertilidad

Valencia, Valencia, 46015, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21055747DERIVED

MeSH Terms

Conditions

HyperprolactinemiaEndometriosis

Condition Hierarchy (Ancestors)

HyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 29, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

January 12, 2009

Record last verified: 2009-01

Locations

ES(1)