EndometriosisPhase 2NCT00160433
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Women With Endometriosis.
A Phase 2 study testing Asoprisnil in people with Endometriosis, run by Abbott.
Trial summary
The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis. 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?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Jun 2003
- 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
- Premenopausal women (18-40 years)
- Surgically confirmed endometriosis within 3 years
- History of menstrual cycles between 21 and 35 days
- Moderate or severe pelvic pain OR moderate or severe dysmenorrhea OR moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain
- Negative pregnancy test
- Agrees to use double barrier method of contraception
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- Pap smear with no evidence of malignancy or pre-malignant changes
- Ultrasound with no significant gynecological disorder.
- Otherwise in good health
Who cannot join
- Less than 3 months after having a baby or breast-feeding
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to hormone therapy
- Anticipated need for excluded hormonal therapy or unapproved narcotics
- Current use of an IUD
- History or prolactinoma
About this study
Official title: A Phase II, 3-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Doses of J867 (0.5, 1.5 and 5 mg QD) Versus Placebo in Subjects With Endometriosis
The objective of this study is to determine the safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.
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 if a dose-response relationship exists between asoprisnil and endometriosis-associated pelvic pain and dysmenorrhea or to establish the lowest effective dose of asoprisnil in the treatment of pelvic pain and dysmenorrhea associated with endometriosis. Women with surgically confirmed endometriosis will be administered asoprisnil 0.5, 1.5, and 5 mg tablets or a placebo once daily for 3 months and efficacy will be assessed by improvement in pelvic pain, dysmenorrhea, dyspareunia, bleeding, analgesic use, global efficacy, and quality of life questionnaires. 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, Placebo
- 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
0.5 mg Tablet, oral Daily for 12 weeks
AsoprisnilDrug
1.5 mg Tablet, oral Daily for 12 weeks
AsoprisnilDrug
5.0 mg Tablet, oral Daily for 12 weeks
PlaceboDrug
Tablet, oral Daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Asoprisnil |
| 2 | Experimental | Not described Receives: Drug: Asoprisnil |
| 3 | Experimental | Not described Receives: Drug: Asoprisnil |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in pelvic pain as assessed by daily diary
Measured: Final month
Mean change from baseline in dysmenorrhea as assessed by daily diary
Measured: Final month
Secondary outcomes (13)
Change from baseline in pelvic pain and dysmenorrhea scores from the daily diary.
Measured: Months 1,2,3 and Months 1-3
Change from baseline in dyspareunia and the combined pelvic pain/dysmenorrhea scores from the daily diary.
Measured: Months 1,2,3 and Months 1-3 and the Final Month
Change from baseline in the percentage of days with mild or greater combined pelvic pain/dysmenorrhea and moderate or greater combined pelvic pain/dysmenorrhea based on the daily diary.
Measured: Months 1,2,3 and Months 1-3 and Final Month
Change from baseline for pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration scores assessed by the modified Biberoglu and Behrman pain scale.
Measured: Months 1,2,3 and Final Visit
Change from baseline in pelvic pain and dysmenorrhea assessed via the Visual Analog Scale.
Measured: Months 1,2,3 and Final Visit
Percent of subjects with "Yes" response to Global Efficacy question.
Measured: Months 1,2,3 and Final Visit
Change from baseline in analgesic use scores.
Measured: Months 1,2,3, Months 1-3 and Final Visit
Percent of subjects who achieve amenorrhea.
Measured: Throughout the treatment period
Change from baseline in Endometriosis Health Profile-30 (EHP-30) scores.
Measured: Month 3
Change from baseline in Short Form-36 scores.
Measured: Month 3
Change from baseline in both monthly bleeding scores and percentage of days with bleeding or spotting.
Measured: Months 1-3
Change from Screening menses in bleeding intensity.
Measured: First post-treatment menses
Change from baseline in hemoglobin and hematocrit.
Measured: Months 1,2,3 and Final Visit
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 startAug 2002
- Primary completionJun 2003
- Study completionJun 2003
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jenapharm GmbH & Co. KG
- Investigators
- Medical Director, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160433
- Sponsor's protocol ID
- M01-398
- 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 II, 3-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Doses of J867 (0.5, 1.5 and 5 mg QD) Versus Placebo in Subjects With Endometriosis
- ClinicalTrials.gov ID
- NCT00160433
- Acronym / sponsor ID
- M01-398
- Conditions
- Endometriosis
- Keywords
- Pelvic pain, Dysmenorrhea, Dyspareunia, Infertility, asoprisnil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Jenapharm GmbH & Co. KG
- Study start
- Aug 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (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 safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in women with endometriosis.
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 if a dose-response relationship exists between asoprisnil and endometriosis-associated pelvic pain and dysmenorrhea or to establish the lowest effective dose of asoprisnil in the treatment of pelvic pain and dysmenorrhea associated with endometriosis. Women with surgically confirmed endometriosis will be administered asoprisnil 0.5, 1.5, and 5 mg tablets or a placebo once daily for 3 months and efficacy will be assessed by improvement in pelvic pain, dysmenorrhea, dyspareunia, bleeding, analgesic use, global efficacy, and quality of life questionnaires. 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Asoprisnil |
| 2 | Experimental | Drug: Asoprisnil |
| 3 | Experimental | Drug: Asoprisnil |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Premenopausal women (18-40 years)
- Surgically confirmed endometriosis within 3 years
- History of menstrual cycles between 21 and 35 days
- Moderate or severe pelvic pain OR moderate or severe dysmenorrhea OR moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain
- Negative pregnancy test
Key exclusion criteria (6 listed)
- Less than 3 months after having a baby or breast-feeding
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to hormone therapy
- Anticipated need for excluded hormonal therapy or unapproved narcotics
- Current use of an IUD
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 |
|---|---|---|
| Asoprisnil0.5 mg Tablet, oral Daily for 12 weeks | Drug | 1 |
| Asoprisnil1.5 mg Tablet, oral Daily for 12 weeks | Drug | 2 |
| Asoprisnil5.0 mg Tablet, oral Daily for 12 weeks | Drug | 3 |
| PlaceboTablet, oral Daily for 12 weeks | Drug | 4 |
Primary outcome
Mean change from baseline in pelvic pain as assessed by daily diary
Time frame: Final month
Mean change from baseline in dysmenorrhea as assessed by daily diary
Time frame: Final month
13 secondary outcomes
Change from baseline in pelvic pain and dysmenorrhea scores from the daily diary.
Time frame: Months 1,2,3 and Months 1-3
Change from baseline in dyspareunia and the combined pelvic pain/dysmenorrhea scores from the daily diary.
Time frame: Months 1,2,3 and Months 1-3 and the Final Month
Change from baseline in the percentage of days with mild or greater combined pelvic pain/dysmenorrhea and moderate or greater combined pelvic pain/dysmenorrhea based on the daily diary.
Time frame: Months 1,2,3 and Months 1-3 and Final Month
Change from baseline for pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration scores assessed by the modified Biberoglu and Behrman pain scale.
Time frame: Months 1,2,3 and Final Visit
Change from baseline in pelvic pain and dysmenorrhea assessed via the Visual Analog Scale.
Time frame: Months 1,2,3 and Final Visit
Percent of subjects with "Yes" response to Global Efficacy question.
Time frame: Months 1,2,3 and Final Visit
Change from baseline in analgesic use scores.
Time frame: Months 1,2,3, Months 1-3 and Final Visit
Percent of subjects who achieve amenorrhea.
Time frame: Throughout the treatment period
Change from baseline in Endometriosis Health Profile-30 (EHP-30) scores.
Time frame: Month 3
Change from baseline in Short Form-36 scores.
Time frame: Month 3
Change from baseline in both monthly bleeding scores and percentage of days with bleeding or spotting.
Time frame: Months 1-3
Change from Screening menses in bleeding intensity.
Time frame: First post-treatment menses
Change from baseline in hemoglobin and hematocrit.
Time frame: Months 1,2,3 and Final Visit
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 9 inclusion and 6 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. Some participants in this study may receive a placebo. 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?
Mean change from baseline in pelvic pain as assessed by daily diary (time frame: Final month). 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; AzTrials last refreshed its copy on 7 Nov 2026.