EndometriosisPhase 2NCT00244452
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 Phase 2 study testing Cetrorelix in people with Endometriosis, run by Solvay Pharmaceuticals at 57 sites in 8 countries.
Trial summary
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Cetrorelix
- How many people
- Not given
- Where
- 57 sitesin 8 countries
- Study dates
- Nov 2005to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
57 sites in 8 countries.
57 sites in 8 countries
Russia16 sites
Site 0701
Moscow
Site 0901
Moscow
Site 0902
Moscow
Site 0903
Moscow
Site 0904
Moscow
Site 0905
Moscow
Site 0906
Moscow
Site 0907
Moscow
Site 0908
Moscow
Site 0909
Moscow
Site 0702
Saint Petersburg
Site 0703
Saint Petersburg
Site 0704
Saint Petersburg
Site 0705
Saint Petersburg
Site 0706
Saint Petersburg
Site 0707
Saint Petersburg
Romania10 sites
Site 4000
Bucharest
Site 4001
Bucharest
Site 4002
Bucharest
Site 4004
Bucharest
Site 4005
Bucharest
Site 4006
Bucharest
Site 4007
Bucharest
Site 4009
Bucharest
Site 4008
Constanța
Site 4003
Craiova
Ukraine8 sites
Site 3805
Dnipro
Site 3801
Donetsk
Site 3803
Kiev
Site 3806
Kiev
Site 3807
Kiev
Site 3808
Kiev
Site 3802
Odesa
Site 3804
Zaporizhzhya
Bulgaria6 sites
Site 3501
Sofia
Site 3502
Sofia
Site 3503
Sofia
Site 3504
Sofia
Site 3505
Sofia
Site 3506
Sofia
Germany5 sites
Site 4904
Berlin
Site 4905
Dresden
Site 4903
Heidelberg
Site 4901
Herne
Site 4902
Tübingen
South Africa5 sites
Site 2705
Bloemfontein
Site 2703
Cape Town
Site 2702
Centurion
Site 2701
Roodepoort
Site 2704
Roodepoort
Australia4 sites
Site 6101
Clayton
Site 6103
Nedlands
Site 6104
Randwick
Site 6102
Sydney
About this study
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief
- Conditions
- Endometriosis
- Being tested
- Cetrorelix
- Keywords
- Endometriosis, Cetrorelix, Hormone, Symptoms relief, Safety, Tolerability, Pharmacodynamic, Pharmacokinetic
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetrorelixDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244452
- Sponsor's protocol ID
- S184.2.101
- Other IDs
- 2004-004739-67, 2004
- Status last verified
- Mar 2008
- First submitted
- 25 Oct 2005
- Last updated
- 31 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00244452
- Acronym / sponsor ID
- S184.2.101
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Cetrorelix, Hormone, Symptoms relief, Safety, Tolerability, Pharmacodynamic, Pharmacokinetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 26 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identify effective doses of cetrorelix SR in the treatment of symptoms of endometriosis, describe dose effect relationship and duration of symptom relief
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetrorelix | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
57 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetrorelix in people with Endometriosis, run by Solvay Pharmaceuticals at 57 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Russia, Romania, Ukraine, Bulgaria, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2008.