Uterine FibroidsPhase 2NCT00150644
A Study to Evaluate the Effects of Asoprisnil(J867) in Women With Uterine Fibroids Who Are Scheduled for a Hysterectomy
A Phase 2 study testing Asoprisnil in people with Uterine Fibroids and Leiomyoma, run by Abbott.
Trial summary
The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids, 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
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to May 2005
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal women, at least 18 years of age
- Diagnosis of uterine fibroid(s), confirmed by ultrasound
- History of menstrual cycles between 17 and 42 days
- Otherwise in good health
- Scheduled for a hysterectomy at the end of the treatment period
- Negative pregnancy test
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- Agrees to double barrier method of contraception
- Pap test with no evidence of malignancy or pre-malignant changes
- Endometrial biopsy with no significant histological disorder
Who cannot join
- Less than 3 months after having a baby or breast-feeding
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to or are currently using any hormone therapy
- History of cancer or alcohol or drug abuse
- Diagnosis of Polycystic Ovary Syndrome
- History of prolactinoma
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- Current use of Intrauterine Device
- Significant gynecological disorder
- Uterine size > 32 weeks gestation
- Current diagnosis of endometriosis
- Uterine artery embolization within 6 months
About this study
Official title: A Phase 2, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
The objective of this study is to evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and 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 effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.
- Conditions
- Uterine Fibroids, Leiomyoma
- Being tested
- Asoprisnil, Placebo
- Keywords
- Fibroid Uterus, Leiomyoma, Uterine Fibroids, Hysterectomy, 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
Also called J867
Asoprisnil 10mg Tablet, oral Daily for 12 weeks
AsoprisnilDrug
Also called J867
Asoprisnil 25 mg Tablet, oral Daily for 12 weeks
PlaceboDrug
Placebo 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 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Measured: Final visit
Secondary outcomes (8)
Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.
Measured: Final Visit
Morphological changes in the endometrium, myometrium and uterine fibroids.
Measured: Final Visit
Change from baseline in menstrual pictogram score.
Measured: Final Month
Percent change from baseline in volume of the largest fibroid.
Measured: Final Visit
Endometrial thickness (post-treatment histologic evaluation).
Measured: Final Visit
Change from baseline in endometrial thickness by transvaginal ultrasound.
Measured: Final Visit
Percent of ovulatory subjects.
Measured: Final Month
Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
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 posted8 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionMay 2005
- Study completionMay 2005
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 Uterine FibroidsStudies 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
- 33 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
- NCT00150644
- Sponsor's protocol ID
- C02-003
- Status last verified
- May 2008
- First submitted
- 6 Sep 2005
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams AR, Critchley HO, Osei J, Ingamells S, Cameron IT, Han C, Chwalisz K. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod. 2007 Jun;22(6):1696-704. doi: 10.1093/humrep/dem026. Epub 2007 Mar 5.
PubMed 17339234
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, 12-Week, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of J867 on Uterine Artery Blood Flow and the Morphology of the Endometrium, Myometrium, and Uterine Leiomyomata in Subjects With Uterine Leiomyomata Scheduled for Hysterectomy.
- ClinicalTrials.gov ID
- NCT00150644
- Acronym / sponsor ID
- C02-003
- Conditions
- Uterine Fibroids, Leiomyoma
- Keywords
- Fibroid Uterus, Leiomyoma, Uterine Fibroids, Hysterectomy, Asoprisnil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 8 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 evaluate the effects of 10 mg and 25 mg doses of asoprisnil, compared to placebo, taken daily for 12 weeks, on uterine blood flow and the morphology of the endometrium and 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 effects of asoprisnil in uterine fibroid growth suppression. Full thickness biopsies obtained from surgical procedures will allow the assessment of asoprisnil's effects on the basalis, the myometrium, and on endometrial angiogenesis. Various other exploratory immunohistological and biochemical specimens will be collected to evaluate the mechanisms of action of asoprisnil in the endometrium, the myometrium, and in uterine fibroids.
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 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Premenopausal women, at least 18 years of age
- Diagnosis of uterine fibroid(s), confirmed by ultrasound
- History of menstrual cycles between 17 and 42 days
- Otherwise in good health
- Scheduled for a hysterectomy at the end of the treatment period
Key exclusion criteria (11 listed)
- Less than 3 months after having a baby or breast-feeding
- Any abnormal lab or procedure result the study-doctor considers important
- Severe reaction(s) to or are currently using any hormone therapy
- History of cancer or alcohol or drug abuse
- Diagnosis of Polycystic Ovary Syndrome
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 10mg Tablet, oral Daily for 12 weeks | Drug | 1 |
| AsoprisnilAlso: J867Asoprisnil 25 mg Tablet, oral Daily for 12 weeks | Drug | 2 |
| PlaceboPlacebo Tablet, oral Daily for 12 weeks | Drug | 3 |
Primary outcome
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index.
Time frame: Final visit
8 secondary outcomes
Change from baseline in uterine artery blood flow as determined by change in Pulsatility Index.
Time frame: Final Visit
Morphological changes in the endometrium, myometrium and uterine fibroids.
Time frame: Final Visit
Change from baseline in menstrual pictogram score.
Time frame: Final Month
Percent change from baseline in volume of the largest fibroid.
Time frame: Final Visit
Endometrial thickness (post-treatment histologic evaluation).
Time frame: Final Visit
Change from baseline in endometrial thickness by transvaginal ultrasound.
Time frame: Final Visit
Percent of ovulatory subjects.
Time frame: Final Month
Change from baseline in the Uterine Fibroid Symptom-Quality of Life total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.
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.
- Results publication: PubMed 17339234Williams AR, Critchley HO, Osei J, Ingamells S, Cameron IT, Han C, Chwalisz K. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod. 2007 Jun;22(6):1696-704. doi: 10.1093/humrep/dem026. Epub 2007 Mar 5.
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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 Uterine Fibroids 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 9 inclusion and 11 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?
Change from baseline to the Final Visit in uterine artery blood flow as determined by change in Resistance Index. (time frame: Final visit). 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 NCT00150644, 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.