Clinical trial NCT00244452: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis
Cetrorelix
Hormone
Symptoms relief
Safety
Tolerability
Pharmacodynamic
Pharmacokinetic
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-10-26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Site 6101
city: Nedlands
country: Australia
facility: Site 6103
city: Randwick
country: Australia
facility: Site 6104
city: Sydney
country: Australia
facility: Site 6102
city: Aalter
country: Belgium
facility: Site 3201
city: Brussels
country: Belgium
facility: Site 3202
city: Leuven
country: Belgium
facility: Site 3203
city: Sofia
country: Bulgaria
facility: Site 3501
city: Sofia
country: Bulgaria
facility: Site 3502
city: Sofia
country: Bulgaria
facility: Site 3503
city: Sofia
country: Bulgaria
facility: Site 3504
city: Sofia
country: Bulgaria
facility: Site 3505
city: Sofia
country: Bulgaria
facility: Site 3506
city: Berlin
country: Germany
facility: Site 4904
city: Dresden
country: Germany
facility: Site 4905
city: Heidelberg
country: Germany
facility: Site 4903
city: Herne
country: Germany
facility: Site 4901
city: Tuebingen
country: Germany
facility: Site 4902
city: Bucuresti
country: Romania
facility: Site 4000
city: Bucuresti
country: Romania
facility: Site 4001
city: Bucuresti
country: Romania
facility: Site 4002
city: Bucuresti
country: Romania
facility: Site 4004
city: Bucuresti
country: Romania
facility: Site 4005
city: Bucuresti
country: Romania
facility: Site 4006
city: Bucuresti
country: Romania
facility: Site 4007
city: Bucuresti
country: Romania
facility: Site 4009
city: Constanta
country: Romania
facility: Site 4008
city: Craiova
country: Romania
facility: Site 4003
city: Moscow
country: Russian Federation
facility: Site 0701
city: Moscow
country: Russian Federation
facility: Site 0901
city: Moscow
country: Russian Federation
facility: Site 0902
city: Moscow
country: Russian Federation
facility: Site 0903
city: Moscow
country: Russian Federation
facility: Site 0904
city: Moscow
country: Russian Federation
facility: Site 0905
city: Moscow
country: Russian Federation
facility: Site 0906
city: Moscow
country: Russian Federation
facility: Site 0907
city: Moscow
country: Russian Federation
facility: Site 0908
city: Moscow
country: Russian Federation
facility: Site 0909
city: St. Petersburg
country: Russian Federation
facility: Site 0702
city: St. Petersburg
country: Russian Federation
facility: Site 0703
city: St. Petersburg
country: Russian Federation
facility: Site 0704
city: St. Petersburg
country: Russian Federation
facility: Site 0705
city: St. Petersburg
country: Russian Federation
facility: Site 0706
city: St. Petersburg
country: Russian Federation
facility: Site 0707
city: Bloemfontein
country: South Africa
facility: Site 2705
city: Cape Town
country: South Africa
facility: Site 2703
city: Centurion
country: South Africa
facility: Site 2702
city: Roodepoort
country: South Africa
facility: Site 2701
city: Roodepoort
country: South Africa
facility: Site 2704
city: Dnepropetrovsk
country: Ukraine
facility: Site 3805
city: Donetsk
country: Ukraine
facility: Site 3801
city: Kiev
country: Ukraine
facility: Site 3803
city: Kiev
country: Ukraine
facility: Site 3806
city: Kiev
country: Ukraine
facility: Site 3807
city: Kiev
country: Ukraine
facility: Site 3808
city: Odessa
country: Ukraine
facility: Site 3802
city: Zaporozhye
country: Ukraine
facility: Site 3804
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: