Fibroid UterusPhase 3NCT00152256
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With 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 safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata. Read more about this study
- Who is it for?
- Ages 18 to 53 years, 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?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Feb 2005
- 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 to 53 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women
- History of regular menstrual cycles (21-42 days)
- Diagnosis of uterine fibroid(s)
- Abnormal vaginal bleeding associated with uterine fibroids
- Otherwise in good health
- Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3
Who cannot join
- Less than 3 months postpartum and post-lactation
- Previous myomectomy within 1 year
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to or are currently using any hormone therapy
- History of osteoporosis or other bone disease
About this study
Official title: A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.
Read the detailed description
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.
- Conditions
- Fibroid Uterus, Leiomyoma, Menorrhagia, Metrorrhagia, Uterine Fibroids
- Being tested
- Asoprisnil, Placebo
- 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 6 months
AsoprisnilDrug
Also called J867
Asoprisnil 25mg Tablet, oral Daily for 6 months
PlaceboDrug
Placebo Tablet, oral Daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Asoprisnil |
| 2 | Experimental | Not described Receives: Drug: Asoprisnil |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative percent of subjects achieving amenorrhea.
Measured: Month 3
Secondary outcomes (9)
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-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 the Work Limitation Questionnaire Index.
Measured: Final Visit
Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).
Measured: Final Visit
Change from baseline in the monthly bleeding score.
Measured: Final Visit
Change from baseline in the hemoglobin concentration.
Measured: Final Visit
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 during treatment.
Measured: During treatment period
Percentage of subjects who respond positively to the global efficacy question.
Measured: Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionFeb 2005
- Study completionFeb 2005
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 239 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
- NCT00152256
- Sponsor's protocol ID
- C02-037
- Status last verified
- May 2008
- First submitted
- 7 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
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 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata
- ClinicalTrials.gov ID
- NCT00152256
- Acronym / sponsor ID
- C02-037
- 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
- 239 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 9 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 effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.
Detailed description
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Asoprisnil |
| 2 | Experimental | Drug: Asoprisnil |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Premenopausal women
- History of regular menstrual cycles (21-42 days)
- Diagnosis of uterine fibroid(s)
- Abnormal vaginal bleeding associated with uterine fibroids
- Otherwise in good health
Key exclusion criteria (5 listed)
- Less than 3 months postpartum and post-lactation
- Previous myomectomy within 1 year
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to or are currently using any hormone therapy
- History of osteoporosis or other bone disease
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 6 months | Drug | 1 |
| AsoprisnilAlso: J867Asoprisnil 25mg Tablet, oral Daily for 6 months | Drug | 2 |
| PlaceboPlacebo Tablet, oral Daily for 6 months | Drug | 3 |
Primary outcome
Cumulative percent of subjects achieving amenorrhea.
Time frame: Month 3
9 secondary outcomes
Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-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 the Work Limitation Questionnaire Index.
Time frame: Final Visit
Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).
Time frame: Final Visit
Change from baseline in the monthly bleeding score.
Time frame: Final Visit
Change from baseline in the hemoglobin concentration.
Time frame: Final Visit
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 during treatment.
Time frame: During treatment period
Percentage of subjects who respond positively to the global efficacy question.
Time frame: 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 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 6 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. 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 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?
Cumulative percent of subjects achieving amenorrhea. (time frame: Month 3). 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 6 Nov 2026.