EndometriosisPhase 3NCT00225199
Efficacy and Safety of SH T00660AA in Treatment of Endometriosis
A Phase 3 study testing Visanne (BAY86-5258, SH T00660AA) in people with Endometriosis, run by Bayer.
Trial summary
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Visanne (BAY86-5258, SH T00660AA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Sep 2006
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with endometriosis-associated pelvic pain
Who cannot join
- Pregnant or lactating women
- history or suspicion of hormone dependent tumor
- therapy resistant endometriosis
- need for primary surgical treatment
- any other conditions which forbid the participation.
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis
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
- Endometriosis
- Being tested
- Visanne (BAY86-5258, SH T00660AA), Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visanne (BAY86-5258, SH T00660AA)Drug
orally once daily
PlaceboDrug
orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Visanne (BAY86-5258, SH T00660AA) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measured: Assessment of pain relief at end of treatment
Secondary outcomes (2)
Adverse event collection
Measured: Assessment at end of study
Treatment satisfaction by patient
Measured: Assessment at end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startMar 2004
- Study completionSep 2006
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 EndometriosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225199
- Sponsor's protocol ID
- 91233
- Other IDs
- 307041
- Status last verified
- Apr 2010
- First submitted
- 22 Sep 2005
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Sieverding M, Gerlinger C, Seitz C. Substituting a randomised placebo control group with a historical placebo control in an endometriosis pain trial: a case study re-evaluating trial data using historical control data from another trial. BMJ Open. 2023 Jul 21;13(7):e063188. doi: 10.1136/bmjopen-2022-063188.
PubMed 37479520
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks
- ClinicalTrials.gov ID
- NCT00225199
- Acronym / sponsor ID
- 91233
- Conditions
- Endometriosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 23 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 purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis
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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Visanne (BAY86-5258, SH T00660AA) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients with endometriosis-associated pelvic pain
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- history or suspicion of hormone dependent tumor
- therapy resistant endometriosis
- need for primary surgical treatment
- any other conditions which forbid the participation.
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 |
|---|---|---|
| Visanne (BAY86-5258, SH T00660AA)orally once daily | Drug | Arm 1 |
| Placeboorally once daily | Drug | Arm 2 |
Primary outcome
Efficacy
Time frame: Assessment of pain relief at end of treatment
2 secondary outcomes
Adverse event collection
Time frame: Assessment at end of study
Treatment satisfaction by patient
Time frame: Assessment at end of study
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 23 Apr 2010.
- Derived from this study: PubMed 37479520Sieverding M, Gerlinger C, Seitz C. Substituting a randomised placebo control group with a historical placebo control in an endometriosis pain trial: a case study re-evaluating trial data using historical control data from another trial. BMJ Open. 2023 Jul 21;13(7):e063188. doi: 10.1136/bmjopen-2022-063188.
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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 3 study testing Visanne (BAY86-5258, SH T00660AA) in people with Endometriosis, 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 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 23 Apr 2010. 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?
Efficacy (time frame: Assessment of pain relief at end of treatment). 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 NCT00225199, 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 23 Apr 2010.