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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00244452




Registration number
NCT00244452
Ethics application status
Date submitted
25/10/2005
Date registered
26/10/2005
Date last updated
31/03/2008

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2004-004739-67
Secondary ID [2] 0 0
S184.2.101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cetrorelix

Treatment: Drugs: Cetrorelix
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site 6101 - Clayton
Recruitment hospital [2] 0 0
Site 6103 - Nedlands
Recruitment hospital [3] 0 0
Site 6104 - Randwick
Recruitment hospital [4] 0 0
Site 6102 - Sydney
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Nedlands
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalter
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sofia
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Germany
State/province [6] 0 0
Dresden
Country [7] 0 0
Germany
State/province [7] 0 0
Heidelberg
Country [8] 0 0
Germany
State/province [8] 0 0
Herne
Country [9] 0 0
Germany
State/province [9] 0 0
Tuebingen
Country [10] 0 0
Romania
State/province [10] 0 0
Bucuresti
Country [11] 0 0
Romania
State/province [11] 0 0
Constanta
Country [12] 0 0
Romania
State/province [12] 0 0
Craiova
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Moscow
Country [14] 0 0
Russian Federation
State/province [14] 0 0
St. Petersburg
Country [15] 0 0
South Africa
State/province [15] 0 0
Bloemfontein
Country [16] 0 0
South Africa
State/province [16] 0 0
Cape Town
Country [17] 0 0
South Africa
State/province [17] 0 0
Centurion
Country [18] 0 0
South Africa
State/province [18] 0 0
Roodepoort
Country [19] 0 0
Ukraine
State/province [19] 0 0
Dnepropetrovsk
Country [20] 0 0
Ukraine
State/province [20] 0 0
Donetsk
Country [21] 0 0
Ukraine
State/province [21] 0 0
Kiev
Country [22] 0 0
Ukraine
State/province [22] 0 0
Odessa
Country [23] 0 0
Ukraine
State/province [23] 0 0
Zaporozhye

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Solvay Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis,
describe dose effect relationship and duration of symptom relief
Trial website
https://clinicaltrials.gov/ct2/show/NCT00244452
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Director Solvay
Address 0 0
Solvay Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries