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

Solvay

Status and phase

Completed

Phase 2

Conditions

Endometriosis

Treatments

Drug: Cetrorelix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00244452

2004-004739-67

S184.2.101

Details and patient eligibility

About

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

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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