EndometriosisPhase 3NCT00225186
Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
A Phase 3 study testing Visanne (SH T00660AA , BAY86-5258) in people with Endometriosis, run by Bayer at 28 sites in 3 countries.
Trial summary
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for 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 (SH T00660AA , BAY86-5258)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 28 sitesin 3 countries
- Study dates
- Jul 2004to Mar 2008
- 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 or need for primary surgical treatment
- Any other conditions which forbid the participation
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
Germany17 sites
Study site
Aachen, North Rhine-Westphalia, 52074
Study site
Dippoldiswalde, Saxony, 01744
Study site
Gevelsberg, North Rhine-Westphalia, 58285
Study site
Giessen, Hesse, 35392
Study site
Greifswald, 17487
Study site
Heidelberg, Baden-Wurttemberg, 69115
Study site
Kalbe, Saxony-Anhalt, 39624
Study site
Krumbach, Bavaria, 86381
Study site
Leipzig, Saxony, 04103
Study site
Lübeck, Schleswig-Holstein, 23538
Study site
Marienberg, Saxony, 09496
Study site
Mühlheim am Main, Hesse, 63165
Study site
München, Bavaria, 81241
Study site
Münster, North Rhine-Westphalia, 48129
Study site
Nuremberg, Bavaria, 90419
Study site
Tübingen, Baden-Wurttemberg, 72076
Study site
Weißig, Saxony, 01474
Ukraine6 sites
Study site
Chernivtsi, 58017
Study site
Kiev, 01030
Study site
Kiev, 04050
Study site
Kiev, 04107
Study site
Kiev, 04210
Study site
Vinnitsa, 21000
Italy5 sites
Study site
Brescia, 25123
Study site
Cagliari, 09042
Study site
Naples, 80138
Study site
Roma, 00165
Study site
Torino, 10127
About this study
Official title: A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for 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 (SH T00660AA , BAY86-5258)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visanne (SH T00660AA , BAY86-5258)Drug
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Visanne (SH T00660AA , BAY86-5258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment of the drug
Measured: 12-18 months
Secondary outcomes (1)
Efficacy (reduction of pelvic pain)
Measured: 12-18 months
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 startJul 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225186
- Sponsor's protocol ID
- 91234
- Other IDs
- 307059
- Status last verified
- Jan 2014
- First submitted
- 22 Sep 2005
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):193-8. doi: 10.1016/j.ejogrb.2010.04.002. Epub 2010 May 5.
PubMed 20444534Kohler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis. Int J Gynaecol Obstet. 2010 Jan;108(1):21-5. doi: 10.1016/j.ijgo.2009.08.020.
PubMed 19819448Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138.
PubMed 21106059Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T. Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet. 2012 Jan;285(1):167-73. doi: 10.1007/s00404-011-1941-7. Epub 2011 Jun 17.
PubMed 21681516
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)
- ClinicalTrials.gov ID
- NCT00225186
- Acronym / sponsor ID
- 91234
- Conditions
- Endometriosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (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 for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Visanne (SH T00660AA , BAY86-5258) |
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 (4 listed)
- Pregnant or lactating women
- History or suspicion of hormone dependent tumor
- Therapy resistant endometriosis or 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 (SH T00660AA , BAY86-5258)Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients | Drug | Arm 1 |
Primary outcome
Safety assessment of the drug
Time frame: 12-18 months
1 secondary outcome
Efficacy (reduction of pelvic pain)
Time frame: 12-18 months
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 9 Jan 2014.
- Results publication: PubMed 20444534Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):193-8. doi: 10.1016/j.ejogrb.2010.04.002. Epub 2010 May 5.
- Results publication: PubMed 19819448Kohler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis. Int J Gynaecol Obstet. 2010 Jan;108(1):21-5. doi: 10.1016/j.ijgo.2009.08.020.
- Results publication: PubMed 21106059Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138.
- Results publication: PubMed 21681516Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T. Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet. 2012 Jan;285(1):167-73. doi: 10.1007/s00404-011-1941-7. Epub 2011 Jun 17.
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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
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Visanne (SH T00660AA , BAY86-5258) in people with Endometriosis, run by Bayer at 28 sites in 3 countries.
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 4 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 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Ukraine, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Safety assessment of the drug (time frame: 12-18 months). 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 NCT00225186, which also lists 4 linked publications.
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 9 Jan 2014.