PostmenopausePhase 2NCT00152295
A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
A Phase 2 study testing Asoprisnil/Premarin in people with Postmenopause, run by Abbott.
Trial summary
The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg Read more about this study
- Who is it for?
- Ages 48 to 65 years, women only
- Conditions the study is for
- Postmenopause
- What is being tested?
- Asoprisnil/Premarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Dec 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 48 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Successful completion of study M00-198
- Continued good general health
- Negative urine pregnancy test
Who cannot join
- History of known or suspected cancer other than basal cell carcinoma in last 5 years
- History of reproductive endocrine disorder
- Submucous or other symptomatic fibroid which would confound efficacy
- Ovarian mass
- Ongoing treatment with an excluded medication
- Stenosis of the cervix
- Any abnormal lab result the study-doctor considers significant.
About this study
Official title: A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women
The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg
Read the detailed description
The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.
- Conditions
- Postmenopause
- Being tested
- Asoprisnil/Premarin
- Keywords
- Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil, Estrogen Replacement Therapy, postmenopause
- Medical subject headings
- Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asoprisnil/PremarinDrug
10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Asoprisnil/Premarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
Measured: Throughout Study
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
Measured: Months 3,6
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
Measured: Months 3,6
Secondary outcomes (4)
Frequency and amount of vaginal bleeding assessed via daily diary.
Measured: Throughout study
Frequency and severity of hot flushes assessed via daily diary.
Measured: Throughout study
Mean change from baseline in endocrine determinations.
Measured: Months 2,4,and 6
Global efficacy question
Measured: Month 6
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 startApr 2001
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopauseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00152295
- Sponsor's protocol ID
- M01-280
- 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 II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00152295
- Acronym / sponsor ID
- M01-280
- Conditions
- Postmenopause
- Keywords
- Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil, Estrogen Replacement Therapy, postmenopause
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (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 long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg
Detailed description
The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Asoprisnil/Premarin |
Who may qualify
- Ages
- 48 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Successful completion of study M00-198
- Continued good general health
- Negative urine pregnancy test
Key exclusion criteria (7 listed)
- History of known or suspected cancer other than basal cell carcinoma in last 5 years
- History of reproductive endocrine disorder
- Submucous or other symptomatic fibroid which would confound efficacy
- Ovarian mass
- Ongoing treatment with an excluded medication
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 |
|---|---|---|
| Asoprisnil/Premarin10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months | Drug | 1 |
Primary outcome
The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
Time frame: Throughout Study
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
Time frame: Months 3,6
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
Time frame: Months 3,6
4 secondary outcomes
Frequency and amount of vaginal bleeding assessed via daily diary.
Time frame: Throughout study
Frequency and severity of hot flushes assessed via daily diary.
Time frame: Throughout study
Mean change from baseline in endocrine determinations.
Time frame: Months 2,4,and 6
Global efficacy question
Time frame: Month 6
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 2 study testing Asoprisnil/Premarin in people with Postmenopause, 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 7 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 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?
The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System. (time frame: Throughout Study). The study lists 3 primary outcomes in all. 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.