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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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00244452
Enrollment
Unknown
Registered
2005-10-26
Start date
2005-11-30
Completion date
2006-09-30
Last updated
2008-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Endometriosis, Cetrorelix, Hormone, Symptoms relief, Safety, Tolerability, Pharmacodynamic, Pharmacokinetic

Brief summary

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

Interventions

DRUGCetrorelix

Sponsors

Solvay Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Countries

Australia, Belgium, Bulgaria, Germany, Romania, Russia, South Africa, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026