Fibroid UterusPhase 3NCT00156208
Safety of Treatment of Uterine Fibroids With Asoprisnil
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 symptomatic uterine fibroids who completed the 6 month Study C02-037. 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
- 166 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Dec 2006
- 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 that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
- Otherwise good health
- Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
- Agrees to 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
- 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
- Significant gynecological disorder, such as endometrial polyp
About this study
Official title: A Phase III, 18-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 symptomatic uterine fibroids who completed the 6 month Study C02-037.
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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.
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, 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
Also called J867
10mg Tablet, oral Daily for 18 months
AsoprisnilDrug
Also called J867
25 mg Tablet, oral Daily for 18 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.
Long Term Safety
Measured: Throughout 18 month treatment period
Secondary outcomes (11)
Cumulative and incremental amenorrhea rates.
Measured: Each month 1-18
Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
Measured: Final Visit
Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
Measured: Final Visit
Change from baseline in Uterine Fibroid Impact Questionnaire.
Measured: Months 6, 12, 18
Change from baseline in the Work Limitation Questionnaire Index.
Measured: Final Visit
Change from baseline in the two dimensions of the SF-36.
Measured: Final Visit
Change from baseline in the monthly bleeding score.
Measured: Final Month
Change from baseline in the hemoglobin concentration.
Measured: Final Visit
Percent change from baseline in volume of the largest fibroid.
Measured: Final Visit
Percentage of subjects who discontinue with the intent to have surgery for fibroids.
Measured: During Treatment Period
Percentage of subjects who responded positively to the Global Efficacy Questions.
Measured: Months 6, 12, 18
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 startApr 2004
- Primary completionDec 2006
- Study completionDec 2006
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
- 166 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
- NCT00156208
- Sponsor's protocol ID
- C03-062
- Status last verified
- May 2008
- First submitted
- 7 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 III, 18-Month, Extension Study to Evaluate the Safety of Asoprisnil in Subjects With Uterine Leiomyomata
- ClinicalTrials.gov ID
- NCT00156208
- Acronym / sponsor ID
- C03-062
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids
- Keywords
- Symptomatic Uterine Fibroids, Excessive Uterine Bleeding, Uterine Hemorrhage, asoprisnil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (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 symptomatic uterine fibroids who completed the 6 month Study C02-037.
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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.
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 that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
- Otherwise good health
- Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
- Agrees to double-barrier method of contraception
- Adequate endometrial biopsy with no significant histological disorder
Key exclusion criteria (4 listed)
- Any abnormal lab or procedure result(s) the study-doctor considers important
- 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
- Significant gynecological disorder, such as endometrial polyp
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: J86710mg Tablet, oral Daily for 18 months | Drug | 1 |
| AsoprisnilAlso: J86725 mg Tablet, oral Daily for 18 months | Drug | 2 |
Primary outcome
Long Term Safety
Time frame: Throughout 18 month treatment period
11 secondary outcomes
Cumulative and incremental amenorrhea rates.
Time frame: Each month 1-18
Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-Quality of Life total score.
Time frame: Final Visit
Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.
Time frame: Final Visit
Change from baseline in Uterine Fibroid Impact Questionnaire.
Time frame: Months 6, 12, 18
Change from baseline in the Work Limitation Questionnaire Index.
Time frame: Final Visit
Change from baseline in the two dimensions of the SF-36.
Time frame: Final Visit
Change from baseline in the monthly bleeding score.
Time frame: Final Month
Change from baseline in the hemoglobin concentration.
Time frame: Final Visit
Percent change from baseline in volume of the largest fibroid.
Time frame: Final Visit
Percentage of subjects who discontinue with the intent to have surgery for fibroids.
Time frame: During Treatment Period
Percentage of subjects who responded positively to the Global Efficacy Questions.
Time frame: Months 6, 12, 18
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 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 4 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?
Long Term Safety (time frame: Throughout 18 month 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 29 May 2008.