LeiomyomaPhase 3NCT00156195
Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids
A Phase 3 study testing Asoprisnil in people with Leiomyoma and Menorrhagia, run by Abbott.
Trial summary
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyoma, Menorrhagia, Metrorrhagia
- 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
- 523 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jan 2007
- Phase
- Phase 3
- 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
Who may be able to join
- Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Agrees to use of double barrier method of contraception
- Adequate endometrial biopsy with no significant histological disorder
Who cannot join
- Any abnormal lab or procedure result(s) the study-doctor considers important
- Significant gynecological disorder such as confirmed endometrial polyp
- Hemoglobin < 8.0 g/dL
- History of a blood-clotting disorder
- Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
About this study
Official title: A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.
Read the detailed description
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.
Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.
- Conditions
- Leiomyoma, Menorrhagia, Metrorrhagia
- Being tested
- Asoprisnil
- Keywords
- Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage, asoprisnil
- Medical subject headings
- Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsoprisnilDrug
10 mg Tablet, oral Daily for 12 months
AsoprisnilDrug
25 mg Tablet, oral Daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Asoprisnil |
| 2 | Experimental | Not described Receives: Drug: Asoprisnil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Measured: Month 12
Secondary outcomes (8)
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Measured: Month 6
Change from baseline in menstrual pictogram bleeding score.
Measured: Final Month
Change from baseline in the number of days with bleeding.
Measured: Final Month
Change from baseline in hemoglobin concentration.
Measured: Final Visit
Percent change from baseline in the volume of the largest fibroid.
Measured: Final Visit
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
Measured: Final Visit
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
Measured: Final Visit
Cumulative percent of subjects who achieve amenorrhea.
Measured: Each Month
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 startSep 2003
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 523 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
- NCT00156195
- Sponsor's protocol ID
- M01-391
- Status last verified
- May 2008
- First submitted
- 7 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diamond MP, Stewart EA, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids. Hum Reprod Open. 2019 Nov 4;2019(4):hoz027. doi: 10.1093/hropen/hoz027. eCollection 2019.
PubMed 31777761
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 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
- ClinicalTrials.gov ID
- NCT00156195
- Acronym / sponsor ID
- M01-391
- Conditions
- Leiomyoma, Menorrhagia, Metrorrhagia
- Keywords
- Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage, asoprisnil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (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 in women with abnormal uterine bleeding associated with uterine fibroids.
Detailed description
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.
Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Asoprisnil |
| 2 | Experimental | Drug: Asoprisnil |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Agrees to use of double barrier method of contraception
- Adequate endometrial biopsy with no significant histological disorder
Key exclusion criteria (5 listed)
- Any abnormal lab or procedure result(s) the study-doctor considers important
- Significant gynecological disorder such as confirmed endometrial polyp
- Hemoglobin < 8.0 g/dL
- History of a blood-clotting disorder
- Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
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 |
|---|---|---|
| Asoprisnil10 mg Tablet, oral Daily for 12 months | Drug | 1 |
| Asoprisnil25 mg Tablet, oral Daily for 12 months | Drug | 2 |
Primary outcome
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Time frame: Month 12
8 secondary outcomes
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
Time frame: Month 6
Change from baseline in menstrual pictogram bleeding score.
Time frame: Final Month
Change from baseline in the number of days with bleeding.
Time frame: Final Month
Change from baseline in hemoglobin concentration.
Time frame: Final Visit
Percent change from baseline in the volume of the largest fibroid.
Time frame: Final Visit
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
Time frame: Final Visit
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
Time frame: Final Visit
Cumulative percent of subjects who achieve amenorrhea.
Time frame: Each Month
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.
- Derived from this study: PubMed 31777761Diamond MP, Stewart EA, Williams ARW, Carr BR, Myers ER, Feldman RA, Elger W, Mattia-Goldberg C, Schwefel BM, Chwalisz K. A 12-month extension study to evaluate the safety and efficacy of asoprisnil in women with heavy menstrual bleeding and uterine fibroids. Hum Reprod Open. 2019 Nov 4;2019(4):hoz027. doi: 10.1093/hropen/hoz027. eCollection 2019.
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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 3 study testing Asoprisnil in people with Leiomyoma and Menorrhagia, 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 5 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention. (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156195, which also lists 1 linked publication.
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.