LeiomyomaPhase 2NCT00160459
A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids
A Phase 2 study testing Asoprisnil in people with Leiomyoma, run by Abbott.
Trial summary
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Leiomyoma
- 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
- 129 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Jul 2001
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 18 and 49 years of age
- Diagnosis of either 1 or more uterine fibroids
- History of regular menstrual cycles of 21 to 35 days in length.
Who cannot join
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of osteoporosis or other bone disease
- History of uterine artery embolization, cryomyolysis, or electrical myolysis
- Subject currently breast feeding
- Hemoglobin < 8 g/dL at baseline
About this study
Official title: A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
Read the detailed description
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
- Conditions
- Leiomyoma
- Being tested
- Asoprisnil, Placebo
- Keywords
- Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsoprisnilDrug
5 mg Tablet, oral Daily for 12 weeks
AsoprisnilDrug
10 mg Tablet, oral Daily for 12 weeks
AsoprisnilDrug
25 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.
Percent change from baseline in uterine volume and volume of the largest fibroid.
Measured: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
Measured: Day 1 to 1st post treatment menses
Secondary outcomes (6)
Change from baseline in uterine size in gestational weeks.
Measured: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.
Measured: Week 12 and final visit
Percentage of days with bleeding.
Measured: Day 1 through end of 1st post-treatment menses
Changes in hematologic and iron parameters.
Measured: Baseline to each visit
Uterine fibroid symptom improvement.
Measured: Baseline to each visit
Response to Global Efficacy Question regarding improvement in fibroid symptoms.
Measured: Week 12 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 startMay 2000
- Primary completionJul 2001
- Study completionJul 2001
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 129 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
- NCT00160459
- Sponsor's protocol ID
- M99-144
- Status last verified
- May 2008
- First submitted
- 8 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Chwalisz K, Larsen L, Mattia-Goldberg C, Edmonds A, Elger W, Winkel CA. A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata. Fertil Steril. 2007 Jun;87(6):1399-412. doi: 10.1016/j.fertnstert.2006.11.094. Epub 2007 Feb 20.
PubMed 17307170
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, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
- ClinicalTrials.gov ID
- NCT00160459
- Acronym / sponsor ID
- M99-144
- Conditions
- Leiomyoma
- Keywords
- Fibroid Uterus, Leiomyoma, Uterine Fibroids, asoprisnil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (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.
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
Detailed description
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
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 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between 18 and 49 years of age
- Diagnosis of either 1 or more uterine fibroids
- History of regular menstrual cycles of 21 to 35 days in length.
Key exclusion criteria (6 listed)
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to or current use of hormone therapy
- History of osteoporosis or other bone disease
- History of uterine artery embolization, cryomyolysis, or electrical myolysis
- Subject currently breast feeding
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 |
|---|---|---|
| Asoprisnil5 mg Tablet, oral Daily for 12 weeks | Drug | 1 |
| Asoprisnil10 mg Tablet, oral Daily for 12 weeks | Drug | 2 |
| Asoprisnil25 mg Tablet, oral Daily for 12 weeks | Drug | 3 |
| PlaceboTablet, oral Daily for 12 weeks | Drug | 4 |
Primary outcome
Percent change from baseline in uterine volume and volume of the largest fibroid.
Time frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
Time frame: Day 1 to 1st post treatment menses
6 secondary outcomes
Change from baseline in uterine size in gestational weeks.
Time frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6
Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.
Time frame: Week 12 and final visit
Percentage of days with bleeding.
Time frame: Day 1 through end of 1st post-treatment menses
Changes in hematologic and iron parameters.
Time frame: Baseline to each visit
Uterine fibroid symptom improvement.
Time frame: Baseline to each visit
Response to Global Efficacy Question regarding improvement in fibroid symptoms.
Time frame: Week 12 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.
- Results publication: PubMed 17307170Chwalisz K, Larsen L, Mattia-Goldberg C, Edmonds A, Elger W, Winkel CA. A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata. Fertil Steril. 2007 Jun;87(6):1399-412. doi: 10.1016/j.fertnstert.2006.11.094. Epub 2007 Feb 20.
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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 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 3 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?
Percent change from baseline in uterine volume and volume of the largest fibroid. (time frame: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.). 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?
On the ClinicalTrials.gov record for NCT00160459, 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.