MenorrhagiaPhase 2NCT00288691
Menorrhagia Study in Women With Treatment-resistant Menorrhagia
A Phase 2 study testing Asoprisnil (BAY86-5294) in people with Menorrhagia, run by Bayer.
Trial summary
The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Asoprisnil (BAY86-5294)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Jan 2004
- 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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with treatment-resistant menorrhagia scheduled for hysterectomy.
Who cannot join
- Organic causes of menorrhagia
- Current hormone treatment
About this study
Official title: A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days
The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Conditions
- Menorrhagia
- Being tested
- Asoprisnil (BAY86-5294), Placebo
- Keywords
- Treatment-resistant menorrhagia
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asoprisnil (BAY86-5294)Drug
5mg/day
Asoprisnil (BAY86-5294)Drug
10mg/day
Asoprisnil (BAY86-5294)Drug
25mg/day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Asoprisnil (BAY86-5294) |
| Arm 2 | Experimental | Not described Receives: Drug: Asoprisnil (BAY86-5294) |
| Arm 3 | Experimental | Not described Receives: Drug: Asoprisnil (BAY86-5294) |
| Arm 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.
Individual relative change in uterine bleeding scores by PBAC
Measured: Pretreatment cycle treatment phase
Secondary outcomes (4)
Endometrial thickness
Measured: End of treatment
Adverse events collection
Measured: Whole treatment period
Bleeding pattern
Measured: Treatment period
Endometrial histology incl. immunohistochemical evaluations
Measured: End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startNov 2001
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TAP Pharmaceutical Products Inc.
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288691
- Sponsor's protocol ID
- 90955
- Other IDs
- 304667
- Status last verified
- Dec 2014
- First submitted
- 7 Feb 2006
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days
- ClinicalTrials.gov ID
- NCT00288691
- Acronym / sponsor ID
- 90955
- Conditions
- Menorrhagia
- Keywords
- Treatment-resistant menorrhagia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- TAP Pharmaceutical Products Inc.
- Study start
- Nov 2001
- Study completion
- Jan 2004 (actual)
- First posted
- 8 Feb 2006 (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 aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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 |
|---|---|---|
| Arm 1 | Experimental | Drug: Asoprisnil (BAY86-5294) |
| Arm 2 | Experimental | Drug: Asoprisnil (BAY86-5294) |
| Arm 3 | Experimental | Drug: Asoprisnil (BAY86-5294) |
| Arm 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with treatment-resistant menorrhagia scheduled for hysterectomy.
Key exclusion criteria (2 listed)
- Organic causes of menorrhagia
- Current hormone treatment
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 (BAY86-5294)5mg/day | Drug | Arm 1 |
| Asoprisnil (BAY86-5294)10mg/day | Drug | Arm 2 |
| Asoprisnil (BAY86-5294)25mg/day | Drug | Arm 3 |
| PlaceboPlacebo | Drug | Arm 4 |
Primary outcome
Individual relative change in uterine bleeding scores by PBAC
Time frame: Pretreatment cycle treatment phase
4 secondary outcomes
Endometrial thickness
Time frame: End of treatment
Adverse events collection
Time frame: Whole treatment period
Bleeding pattern
Time frame: Treatment period
Endometrial histology incl. immunohistochemical evaluations
Time frame: End of treatment
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 30 Dec 2014.
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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.
Bayer Study Director study director
Bayer
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asoprisnil (BAY86-5294) in people with Menorrhagia, run by Bayer.
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 1 inclusion and 2 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 30 Dec 2014. 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?
Individual relative change in uterine bleeding scores by PBAC (time frame: Pretreatment cycle treatment phase). 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 30 Dec 2014.