EndometriosisESISNCT00761683
Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS
An observational study of Endometriosis, run by AstraZeneca at 3 sites in Romania.
Trial summary
To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- How many people
- 105 participants
- Where
- 3 sitesRomania
- Study dates
- Oct 2008to not given
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The programme will include the patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program.
Who may be able to join
- patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program, according to Romanian approved goserelin 3,6 mg
Who cannot join
- patients who have a known hypersensitivity to goserelin (Zoladex) or any of its excipients or any other GnRH analogue, pregnancy, according to Romanian approved goserelin 3,6 mg SmPC
Trial locations and contacts
3 sites in 1 country.
Romania3 sites
Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Timișoara
About this study
To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.
- Conditions
- Endometriosis
- Keywords
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed with endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biberoglu and Bergham Scale
Measured: monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain
Secondary outcomes (1)
Biberoglu and Bergham Scale
Measured: twice/first and last clinic visit for pelvic tenderness and indurations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startOct 2008
Why it stopped: Anticipated number of patients not achieved. All Patients recruited in the study completed all study visits.
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Cristina Pentiuc, Study director, AstraZeneca Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761683
- Sponsor's protocol ID
- NIS-ORO-ZOL-2007/1
- Acronym
- ESIS
- Status last verified
- Sep 2009
- First submitted
- 26 Sep 2008
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS
- ClinicalTrials.gov ID
- NCT00761683
- Acronym / sponsor ID
- ESIS / NIS-ORO-ZOL-2007/1
- Conditions
- Endometriosis
- Keywords
- Endometriosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Anticipated number of patients not achieved. All Patients recruited in the study completed all study visits.
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- First posted
- 29 Sep 2008 (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.
To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients diagnosed with endometriosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The programme will include the patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program.
Key inclusion criteria (1 listed)
- patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program, according to Romanian approved goserelin 3,6 mg
Key exclusion criteria (1 listed)
- patients who have a known hypersensitivity to goserelin (Zoladex) or any of its excipients or any other GnRH analogue, pregnancy, according to Romanian approved goserelin 3,6 mg SmPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biberoglu and Bergham Scale
Time frame: monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain
1 secondary outcome
Biberoglu and Bergham Scale
Time frame: twice/first and last clinic visit for pelvic tenderness and indurations
Results and safety
The study was stopped early (reason given: Anticipated number of patients not achieved. All Patients recruited in the study completed all study visits.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2009.
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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.
Cristina Pentiuc study director
AstraZeneca Romania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by AstraZeneca at 3 sites in Romania.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Romania. 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.
Are results available for this study?
The study was stopped early (reason given: Anticipated number of patients not achieved. All Patients recruited in the study completed all study visits.). Results are not available in the source record.
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.
What does the primary outcome measure?
Biberoglu and Bergham Scale (time frame: monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain). It is what the study was designed to measure, not a finding.
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 10 Sep 2009.