AmenorrheaPhase 2NCT00152282
A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
A Phase 2 study testing Asoprisnil/Premarin in people with Amenorrhea and Postmenopause, run by Abbott.
Trial summary
The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses 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
- Amenorrhea, Postmenopause
- What is being tested?
- Asoprisnil/Premarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Aug 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
- Postmenopausal women with an intact uterus
- Body mass index (BMI) between 18.0 - 33.0
- Good general health
- Endometrial thickness ≤ 4 mm by TVU
- No history or suspected endometrial hyperplasia
- Negative urine pregnancy test
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- Pap smear in last 6 months with no evidence of malignancy or pre-malignant changes
- Mammogram without suspicion of malignancy within last 6 months
- Endometrial biopsy with no evidence of pathologic changes within last 6 months
Who cannot join
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to hormone therapy
- Receiving hormone therapy
- Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones
- History or known or suspected cancer other than basal cell carcinoma
- Stenosis of the cervix
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- History of reproductive endocrine disorder
- Washout requirement for hormonal therapy not met
- Ovarian mass
- Submucus or other symptomatic fibroid which would confound efficacy
About this study
Official title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women
The objective of this study is to determine the safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.
Read the detailed description
The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include 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
- Amenorrhea, Postmenopause
- Being tested
- Asoprisnil/Premarin, Placebo and Premarin
- Keywords
- Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil
- 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
Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Asoprisnil/PremarinDrug
Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Asoprisnil/PremarinDrug
Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Placebo and PremarinDrug
Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Asoprisnil/Premarin |
| 2 | Experimental | Not described Receives: Drug: Asoprisnil/Premarin |
| 3 | Experimental | Not described Receives: Drug: Asoprisnil/Premarin |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo and Premarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of endometrium by endometrial biopsy
Measured: Week 12
Change from baseline in endometrial thickness as assessed by ultrasound
Measured: Week 12
Secondary outcomes (4)
Frequency and amount of vaginal bleeding via patient diary.
Measured: Week 4, 8, and 12
Incidence of hot flushes
Measured: Week 4, 8, and 12
Presence or absence of endometrial hyperplasia.
Measured: Week 12
Response to global efficacy question regarding improvement in menopause symptoms.
Measured: Week 12
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 2000
- Primary completionAug 2001
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmenorrheaStudies 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
- 105 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
- NCT00152282
- Sponsor's protocol ID
- M00-198
- 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 Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women
- ClinicalTrials.gov ID
- NCT00152282
- Acronym / sponsor ID
- M00-198
- Conditions
- Amenorrhea, Postmenopause
- Keywords
- Postmenopausal, Amenorrhea, Hormone replacement therapy, HRT, asoprisnil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Aug 2001 (actual)
- Study completion
- Aug 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 safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.
Detailed description
The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Asoprisnil/Premarin |
| 2 | Experimental | Drug: Asoprisnil/Premarin |
| 3 | Experimental | Drug: Asoprisnil/Premarin |
| 4 | Placebo comparator | Drug: Placebo and Premarin |
Who may qualify
- Ages
- 48 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Postmenopausal women with an intact uterus
- Body mass index (BMI) between 18.0 - 33.0
- Good general health
- Endometrial thickness ≤ 4 mm by TVU
- No history or suspected endometrial hyperplasia
Key exclusion criteria (10 listed)
- Any abnormal lab result the study-doctor considers significant
- History of severe reaction to hormone therapy
- Receiving hormone therapy
- Currently using phytoestrogenic compounds, such as red clover, black cohosh (Promensil and Remifemin), dong quai, ginseng and soy isoflavones
- History or known or suspected cancer other than basal cell carcinoma
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/PremarinAsoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks | Drug | 1 |
| Asoprisnil/PremarinAsoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks | Drug | 2 |
| Asoprisnil/PremarinAsoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks | Drug | 3 |
| Placebo and PremarinPlacebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks | Drug | 4 |
Primary outcome
Assessment of endometrium by endometrial biopsy
Time frame: Week 12
Change from baseline in endometrial thickness as assessed by ultrasound
Time frame: Week 12
4 secondary outcomes
Frequency and amount of vaginal bleeding via patient diary.
Time frame: Week 4, 8, and 12
Incidence of hot flushes
Time frame: Week 4, 8, and 12
Presence or absence of endometrial hyperplasia.
Time frame: Week 12
Response to global efficacy question regarding improvement in menopause symptoms.
Time frame: Week 12
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 Amenorrhea and 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 9 inclusion and 10 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?
Assessment of endometrium by endometrial biopsy (time frame: Week 12). 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?
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.