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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00244452
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Cetrorelix Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244452


Locations
Hide Hide 57 study locations
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Australia
Site 6101
Clayton, Australia
Site 6103
Nedlands, Australia
Site 6104
Randwick, Australia
Site 6102
Sydney, Australia
Belgium
Site 3201
Aalter, Belgium
Site 3202
Brussels, Belgium
Site 3203
Leuven, Belgium
Bulgaria
Site 3501
Sofia, Bulgaria
Site 3502
Sofia, Bulgaria
Site 3503
Sofia, Bulgaria
Site 3504
Sofia, Bulgaria
Site 3505
Sofia, Bulgaria
Site 3506
Sofia, Bulgaria
Germany
Site 4904
Berlin, Germany
Site 4905
Dresden, Germany
Site 4903
Heidelberg, Germany
Site 4901
Herne, Germany
Site 4902
Tuebingen, Germany
Romania
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
Russian Federation
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
South Africa
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
Ukraine
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
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

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Responsible Party: Gereon Raddatz, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00244452    
Other Study ID Numbers: S184.2.101
2004-004739-67
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008
Keywords provided by Solvay Pharmaceuticals:
Endometriosis
Cetrorelix
Hormone
Symptoms relief
Safety
Tolerability
Pharmacodynamic
Pharmacokinetic
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Cetrorelix
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists