EndometriosisPhase 2NCT00160420
A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398
A Phase 2 study testing Asoprisnil in people with Endometriosis, run by Abbott.
Trial summary
The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Asoprisnil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Jul 2004
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Completed 3 months of dosing and Month 3 procedures in study M01-398
- Otherwise in good health
- Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder
Who cannot join
- Any abnormal lab or procedure result the study-doctor considers important
- Anticipated need for excluded hormonal therapy or unapproved narcotics
About this study
Official title: A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis
The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.
Read the detailed description
Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.
- Conditions
- Endometriosis
- Being tested
- Asoprisnil
- Keywords
- Pelvic pain, Dysmenorrhea, Dyspareunia, Infertility, asoprisnil
- Medical subject headings
- Endometriosis, Pelvic Pain, Dysmenorrhea, Dyspareunia, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsoprisnilDrug
5mg Tablet, oral Daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Asoprisnil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.
Measured: Months 1,3,6,9,12 and final visit
Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.
Measured: Months 3,6,9,12 and final visit
Secondary outcomes (1)
Percentage of subjects with amenorrhea.
Measured: Throught treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2002
- Primary completionJul 2004
- Study completionJul 2004
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160420
- Sponsor's protocol ID
- M02-408
- Status last verified
- May 2008
- First submitted
- 8 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis
- ClinicalTrials.gov ID
- NCT00160420
- Acronym / sponsor ID
- M02-408
- Conditions
- Endometriosis
- Keywords
- Pelvic pain, Dysmenorrhea, Dyspareunia, Infertility, asoprisnil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 12 Sep 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.
The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.
Detailed description
Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Asoprisnil |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Completed 3 months of dosing and Month 3 procedures in study M01-398
- Otherwise in good health
- Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder
Key exclusion criteria (2 listed)
- Any abnormal lab or procedure result the study-doctor considers important
- Anticipated need for excluded hormonal therapy or unapproved narcotics
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 |
|---|---|---|
| Asoprisnil5mg Tablet, oral Daily for 12 months | Drug | 1 |
Primary outcome
Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.
Time frame: Months 1,3,6,9,12 and final visit
Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.
Time frame: Months 3,6,9,12 and final visit
1 secondary outcome
Percentage of subjects with amenorrhea.
Time frame: Throught treatment period.
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 29 May 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.
Medical Director study chair
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asoprisnil in people with Endometriosis, run by Abbott.
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 3 inclusion and 2 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 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale. (time frame: Months 1,3,6,9,12 and final visit). The study lists 2 primary outcomes in all. 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 29 May 2008.