Fibroid UterusPhase 3NCT00156156
Study of Asoprisnil in the Treatment of Uterine Fibroids.
A Phase 3 study testing Asoprisnil in people with Fibroid Uterus and Leiomyoma, 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
- Fibroid Uterus, Leiomyoma, Menorrhagia
- 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
- 149 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Feb 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 active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Adequate endometrial biopsy with no significant histological disorder
- Agrees to use double-barrier method of contraception
Who cannot join
- Any abnormal lab or procedure result(s) the study-doctor considers important
- History of a blood-clotting disorder
- History of osteoporosis requiring treatment
- Any invasive procedure(s) (D\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
- Hemoglobin < 8.0 g/dL
- Endometrial thickness ≥ 19 mm
About this study
Official title: A Phase 3, Continuation Study to Evaluate the Long-Term 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 two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab 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
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids
- Being tested
- Asoprisnil
- Keywords
- Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage
- 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
Also called J867
Asoprisnil 10 mg Tablet, oral Daily for up to 2 years
AsoprisnilDrug
Also called J867
Asoprisnil 25 mg Tablet, oral Daily for up to 2 years
| 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.
Long-term Safety.
Measured: Throughout 2 year treatment period
Secondary outcomes (8)
Change from baseline in the monthly bleeding score and the number of days with bleeding.
Measured: Each Month
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.
Measured: Months 3, 6, 9,12,15,18, 24
Percent change from baseline in volume of the largest fibroid.
Measured: Months 12, 24
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
Measured: Months 6, 12, 18, 24
Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
Measured: Months 6, 12, 18, 24
Change from baseline in the 8 scales of the SF-36 questionnaire.
Measured: Months 6, 12, 18, 24
Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire.
Measured: Months 6, 12, 18, 24
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 startNov 2004
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies 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
- 149 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
- NCT00156156
- Sponsor's protocol ID
- A-FB04-078
- Status last verified
- May 2008
- First submitted
- 7 Sep 2005
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Continuation Study to Evaluate the Long-Term Safety of Asoprisnil in Subjects With Uterine Leiomyomata
- ClinicalTrials.gov ID
- NCT00156156
- Acronym / sponsor ID
- A-FB04-078
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids
- Keywords
- Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 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 two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab 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 active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
- Otherwise in good health
- Premenopausal based on Estrogen and FSH levels
- Adequate endometrial biopsy with no significant histological disorder
- Agrees to use double-barrier method of contraception
Key exclusion criteria (6 listed)
- Any abnormal lab or procedure result(s) the study-doctor considers important
- History of a blood-clotting disorder
- History of osteoporosis requiring treatment
- Any invasive procedure(s) (D\&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
- Hemoglobin < 8.0 g/dL
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 |
|---|---|---|
| AsoprisnilAlso: J867Asoprisnil 10 mg Tablet, oral Daily for up to 2 years | Drug | 1 |
| AsoprisnilAlso: J867Asoprisnil 25 mg Tablet, oral Daily for up to 2 years | Drug | 2 |
Primary outcome
Long-term Safety.
Time frame: Throughout 2 year treatment period
8 secondary outcomes
Change from baseline in the monthly bleeding score and the number of days with bleeding.
Time frame: Each Month
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.
Time frame: Months 3, 6, 9,12,15,18, 24
Percent change from baseline in volume of the largest fibroid.
Time frame: Months 12, 24
Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.
Time frame: Months 6, 12, 18, 24
Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
Time frame: Months 6, 12, 18, 24
Change from baseline in the 8 scales of the SF-36 questionnaire.
Time frame: Months 6, 12, 18, 24
Change from baseline in the 4 scales and overall index of the Work Limitations Questionnaire.
Time frame: Months 6, 12, 18, 24
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 28 May 2008.
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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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 Fibroid Uterus and Leiomyoma, 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 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 28 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?
Long-term Safety. (time frame: Throughout 2 year treatment period). 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 28 May 2008.