CClinicalTrials.gg
CompletedNCT00244452Updated Mar 31, 2008

A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis

A Phase 2 interventional study of Cetrorelix in Endometriosis, sponsored by Solvay Pharmaceuticals. Completed at 57 sites in 8 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2008-03-31.

Sponsored by Solvay Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Endometriosis

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Keywords

  • Endometriosis
  • Cetrorelix
  • Hormone
  • Symptoms relief
  • Safety
  • Tolerability
  • Pharmacodynamic
  • Pharmacokinetic
03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

Browse Endometriosis studies →

Lead sponsor

Solvay Pharmaceuticals is the lead sponsor of 84 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DrugCetrorelix
06

Study locations

57 sites
  • Site 6101
    Clayton, Australia
  • Site 6103
    Nedlands, Australia
  • Site 6104
    Randwick, Australia
  • Site 6102
    Sydney, Australia
  • Site 3201
    Aalter, Belgium
  • Site 3202
    Brussels, Belgium
  • Site 3203
    Leuven, Belgium
  • Site 3501
    Sofia, Bulgaria
  • Site 3502
    Sofia, Bulgaria
  • Site 3503
    Sofia, Bulgaria
  • Site 3504
    Sofia, Bulgaria
  • Site 3505
    Sofia, Bulgaria
  • Site 3506
    Sofia, Bulgaria
  • Site 4904
    Berlin, Germany
  • Site 4905
    Dresden, Germany
  • Site 4903
    Heidelberg, Germany
  • Site 4901
    Herne, Germany
  • Site 4902
    Tuebingen, Germany
  • Site 4000
    Bucuresti, Romania
  • Site 4001
    Bucuresti, Romania
  • Site 4002
    Bucuresti, Romania
  • Site 4004
    Bucuresti, Romania
  • Site 4005
    Bucuresti, Romania
  • Site 4006
    Bucuresti, Romania
  • Site 4007
    Bucuresti, Romania
  • Site 4009
    Bucuresti, Romania
  • Site 4008
    Constanta, Romania
  • Site 4003
    Craiova, Romania
  • Site 0701
    Moscow, Russian Federation
  • Site 0901
    Moscow, Russian Federation
  • Site 0902
    Moscow, Russian Federation
  • Site 0903
    Moscow, Russian Federation
  • Site 0904
    Moscow, Russian Federation
  • Site 0905
    Moscow, Russian Federation
  • Site 0906
    Moscow, Russian Federation
  • Site 0907
    Moscow, Russian Federation
  • Site 0908
    Moscow, Russian Federation
  • Site 0909
    Moscow, Russian Federation
  • Site 0702
    St. Petersburg, Russian Federation
  • Site 0703
    St. Petersburg, Russian Federation
  • Site 0704
    St. Petersburg, Russian Federation
  • Site 0705
    St. Petersburg, Russian Federation
  • Site 0706
    St. Petersburg, Russian Federation
  • Site 0707
    St. Petersburg, Russian Federation
  • Site 2705
    Bloemfontein, South Africa
  • Site 2703
    Cape Town, South Africa
  • Site 2702
    Centurion, South Africa
  • Site 2701
    Roodepoort, South Africa
  • Site 2704
    Roodepoort, South Africa
  • Site 3805
    Dnepropetrovsk, Ukraine
  • Site 3801
    Donetsk, Ukraine
  • Site 3803
    Kiev, Ukraine
  • Site 3806
    Kiev, Ukraine
  • Site 3807
    Kiev, Ukraine
  • Site 3808
    Kiev, Ukraine
  • Site 3802
    Odessa, Ukraine
  • Site 3804
    Zaporozhye, Ukraine
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00244452
Lead sponsor
Solvay Pharmaceuticals
First posted
Oct 26, 2005
Start date
Nov 2005
Primary completion
Sep 2006
Completion
Sep 2006
Last update
Mar 31, 2008

Study contacts

Global Clinical Director Solvay
study director · Solvay Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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