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
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ClinicalTrials.gov Identifier: NCT00244452 |
Recruitment Status
:
Completed
First Posted
: October 26, 2005
Last Update Posted
: March 31, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis | Drug: Cetrorelix | Phase 2 |
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 |


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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | 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:
- 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

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

Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Gereon Raddatz, Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00244452 History of Changes |
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:
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 |