NCT00244452

Brief Summary

Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief

Trial Health

93
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach
8 countries

57 active sites

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

First Submitted

Initial submission to the registry

October 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 31, 2008

Status Verified

March 1, 2008

Enrollment Period

10 months

First QC Date

October 25, 2005

Last Update Submit

March 28, 2008

Conditions

Endometriosis

Keywords

EndometriosisCetrorelixHormoneSymptoms reliefSafetyTolerabilityPharmacodynamicPharmacokinetic

Interventions

CetrorelixDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal female,
  • history of regular menstrual periods,
  • any of the symptoms dysmenorrhea,
  • dyspareunia or pelvic pain assessed as moderate to severe,
  • endometriosis confirmed by histology within 36 months,
  • use of barrier contraception throughout the study

You may not qualify if:

  • Insufficient wash out period for other endometriosis treatments,
  • resection or destruction of endometriotic lesions less than 12 weeks prior to screening,
  • need for strong opioid analgesics,
  • need for immediate surgical treatment of endometriosis,
  • any condition that interferes with adherence to study procedures or study assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

Site 6101

Clayton, Australia

Location

Site 6103

Nedlands, Australia

Location

Site 6104

Randwick, Australia

Location

Site 6102

Sydney, Australia

Location

Site 3201

Aalter, Belgium

Location

Site 3202

Brussels, Belgium

Location

Site 3203

Leuven, Belgium

Location

Site 3501

Sofia, Bulgaria

Location

Site 3502

Sofia, Bulgaria

Location

Site 3503

Sofia, Bulgaria

Location

Site 3504

Sofia, Bulgaria

Location

Site 3505

Sofia, Bulgaria

Location

Site 3506

Sofia, Bulgaria

Location

Site 4904

Berlin, Germany

Location

Site 4905

Dresden, Germany

Location

Site 4903

Heidelberg, Germany

Location

Site 4901

Herne, Germany

Location

Site 4902

Tübingen, Germany

Location

Site 4000

Bucharest, Romania

Location

Site 4001

Bucharest, Romania

Location

Site 4002

Bucharest, Romania

Location

Site 4004

Bucharest, Romania

Location

Site 4005

Bucharest, Romania

Location

Site 4006

Bucharest, Romania

Location

Site 4007

Bucharest, Romania

Location

Site 4009

Bucharest, Romania

Location

Site 4008

Constanța, Romania

Location

Site 4003

Craiova, Romania

Location

Site 0701

Moscow, Russia

Location

Site 0901

Moscow, Russia

Location

Site 0902

Moscow, Russia

Location

Site 0903

Moscow, Russia

Location

Site 0904

Moscow, Russia

Location

Site 0905

Moscow, Russia

Location

Site 0906

Moscow, Russia

Location

Site 0907

Moscow, Russia

Location

Site 0908

Moscow, Russia

Location

Site 0909

Moscow, Russia

Location

Site 0702

Saint Petersburg, Russia

Location

Site 0703

Saint Petersburg, Russia

Location

Site 0704

Saint Petersburg, Russia

Location

Site 0705

Saint Petersburg, Russia

Location

Site 0706

Saint Petersburg, Russia

Location

Site 0707

Saint Petersburg, Russia

Location

Site 2705

Bloemfontein, South Africa

Location

Site 2703

Cape Town, South Africa

Location

Site 2702

Centurion, South Africa

Location

Site 2701

Roodepoort, South Africa

Location

Site 2704

Roodepoort, South Africa

Location

Site 3805

Dnipro, Ukraine

Location

Site 3801

Donetsk, Ukraine

Location

Site 3803

Kiev, Ukraine

Location

Site 3806

Kiev, Ukraine

Location

Site 3807

Kiev, Ukraine

Location

Site 3808

Kiev, Ukraine

Location

Site 3802

Odesa, Ukraine

Location

Site 3804

Zaporizhzhya, Ukraine

Location

MeSH Terms

Conditions

Endometriosis

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 26, 2005

Study Start

November 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

March 31, 2008

Record last verified: 2008-03

Locations

BU(6)BE(3)RU(16)AU(4)ZA(5)UA(8)RO(10)DE(5)