ContraceptionPhase 3NCT00266032
Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles
A Phase 3 study testing Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300), Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) and Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) in people with Contraception, run by Bayer at 35 sites in 3 countries.
Trial summary
The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300), Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) and Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,166 participants
- Where
- 35 sitesin 3 countries
- Study dates
- Dec 2005to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women who desire contraception
- smokers ≤ 30 Years old
Who cannot join
- Contraindication against use of hormonal contraceptives
Trial locations and contacts
35 sites in 3 countries.
35 sites in 3 countries
Germany28 sites
Study site
Ansbach, Bavaria, 91522
Study site
Berlin, State of Berlin, 10115
Study site
Berlin, State of Berlin, 10247
Study site
Berlin, State of Berlin, 12435
Study site
Berlin, State of Berlin, 13187
Study site
Bernburg, Saxony-Anhalt, 06406
Study site
Bovenden, Lower Saxony, 37120
Study site
Dietzenbach, Hesse, 63128
Study site
Ettlingen, Baden-Wurttemberg, 76275
Study site
Frankfurt am Main, Hesse, 60322
Study site
Frankfurt am Main, Hesse, 60439
Study site
Frankfurt am Main, Hesse, 65929
Study site
Frankfurt am Main, Hesse, 65936
Study site
Gera, Thuringia, 07545
Study site
Hamburg, Free and Hanseatic City of Hamburg, 21073
Study site
Hanover, Lower Saxony, 30459
Study site
Jena, Thuringia, 07747
Study site
Jessen, Saxony-Anhalt, 06917
Study site
Kahla, Thuringia, 07768
Study site
Karlsruhe, Baden-Wurttemberg, 76199
Study site
Krumbach, Bavaria, 86381
Study site
Magdeburg, Saxony-Anhalt, 39104
Study site
Magdeburg, Saxony-Anhalt, 39126
Study site
Magdeburg, Saxony-Anhalt, 39130
Study site
Mühlheim am Main, Hesse, 63165
Study site
Nuremberg, Bavaria, 90491
Study site
Osnabrück, Lower Saxony, 49074
Study site
Wurzen, Saxony, 04808
Canada6 sites
Study site
Drummondville, Quebec, J2B 1H8
Study site
Montreal, Quebec, H1T 1P6
Study site
Pointe-Claire, Quebec, H9R 4S3
Study site
Québec, Quebec, G1S 2L6
Study site
Shawinigan, Quebec, G9N 2H6
Study site
Ste-Foy, Quebec, G1V 4X7
About this study
Official title: A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension
The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
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 (BSP AG), Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.
- Conditions
- Contraception
- Being tested
- Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300), Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300), Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)Drug
3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)Drug
3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)Drug
13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
| Study group | Role | What they receive |
|---|---|---|
| Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) | Experimental | 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. Receives: Drug: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) |
| Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) | Experimental | 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected. Receives: Drug: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) |
| Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) | Active comparator | 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected. Receives: Drug: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days With Bleeding Including Spotting
The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.
Measured: up to 1 year
Number of Unintended Pregnancies in Yaz Flexible Arm
Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.
Measured: up to 2 years
Pearl Index
The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.
Measured: Up to 2 years
Number of Unintended Pregnancies Due to Method Failure
Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.
Measured: Up to 2 years
Adjusted Pearl Index
The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.
Measured: Up to 2 years
Secondary outcomes (5)
Number of Days With Bleeding Excluding Spotting
The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity light, normal, or heavy.
Measured: up to 1 year
Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days
For early dropouts and pregnant subjects with an exposure period of less than 1 year but at least 248 days, the number of bleeding/spotting days was normalized to correspond to a 1-year exposure period.
Measured: up to 1 year
Number of Bleeding / Spotting Days by 90-day Reference Period
The mean number of bleeding / spotting days, spotting-only and bleeding days was analyzed using reference periods of 90 days as recommended by the WHO.
Measured: up to 1 year
Number of Bleeding / Spotting Episodes in 90 Day Reference Period
The mean number of bleeding / spotting episodes was analyzed using reference periods of 90 days as recommended by the WHO.
Measured: Up to one year
Days With Scheduled Versus Unscheduled Bleeding
Days with scheduled and unscheduled bleeding were evaluated for extended regimens only. Unscheduled is any bleeding/spotting that occurred while taking active hormones regardless of the duration of intake, unless they occurred after tablet-free interval during days 1-4 of subsequent treatment cycle, or unless they occurred during days 1-7 of first treatment cycle. Scheduled is any bleeding/spotting that occurred during tablet-free interval, regardless of duration of tablet intake, or during next 4 days of subsequent treatment cycle.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,166 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
- NCT00266032
- Sponsor's protocol ID
- 91450
- Other IDs
- 2005-002125-32, 308683, 2005
- Status last verified
- Oct 2014
- First submitted
- 14 Dec 2005
- Last updated
- 3 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Long-term tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):84-93. doi: 10.1136/jfprhc-2011-100214.
PubMed 22454004Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Contraceptive efficacy and tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):73-83. doi: 10.1136/jfprhc-2011-100213.
PubMed 22454003Reif S, Snelder N, Blode H. Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study. J Fam Plann Reprod Health Care. 2013 Apr;39(2):e1-13. doi: 10.1136/jfprhc-2012-100397.
PubMed 23493606
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Randomized, Parallel Group Comparison to Assess the Safety and Efficacy of the Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Betadex Clathrate and 3 mg Drospirenone) in Two Variations of an Extended Regimen vs. a Standard Regimen (24 + 4 Days) in 1122 Healthy Female Volunteers for One Year, Followed by a One Year Safety Extension
- ClinicalTrials.gov ID
- NCT00266032
- Acronym / sponsor ID
- 91450
- Conditions
- Contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,166 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 15 Dec 2005 (estimated)
- Results
- Posted 3 Mar 2010
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 the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) | Experimental | Drug: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. |
| Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) | Experimental | Drug: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected. |
| Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) | Active comparator | Drug: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women who desire contraception
- smokers ≤ 30 Years old
Key exclusion criteria (1 listed)
- Contraindication against use of hormonal contraceptives
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 |
|---|---|---|
| Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300)3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. | Drug | Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) |
| Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300)3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected. | Drug | Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) |
| Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected. | Drug | Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) |
Primary outcome
Number of Days With Bleeding Including Spotting
Time frame: up to 1 year
The number of bleeding days per volunteer was calculated by summing up all days with bleeding intensity spotting or worse. The primary evaluation was the comparison of the flexible extended vs the standard regimen for this primary target variable, which was done for data within the first year of treatment only. As no further comparison or testing was done, no multiplicity issue arose.
Number of Unintended Pregnancies in Yaz Flexible Arm
Time frame: up to 2 years
Pregnancies with conception date within 4 days after end of study medication were regarded as during treatment.
Pearl Index
Time frame: Up to 2 years
The Pearl Index (PI) is defined as the number of pregnancies per 100 woman years. The 2-year PI was obtained by dividing the number of pregnancies that occurred during the two years of treatment by the time (in 100 women years) that the women were under risk of getting pregnant. 95% confidence interval according to European Medicine Agency Note for guidance on clinical investigation of steroid contraceptives in women.
Number of Unintended Pregnancies Due to Method Failure
Time frame: Up to 2 years
Not included in this analysis are pregnancies due to subject failure eg. non-compliance with tablet intake rules.
Adjusted Pearl Index
Time frame: Up to 2 years
The adjusted Pearl Index was based on pregnancies due to method failures and compliant treatment cycles, i.e. cycle length between 24 and 124 day, pill break not longer than 7 days, and number of pills taken not smaller than 90% of the number of days in that cycle minus 7 days.
5 secondary outcomes
Number of Days With Bleeding Excluding Spotting
Time frame: up to 1 year
Number of Bleeding Days During One Year of Treatment in Subjects With at Least 248 Days of Exposure Normalized to 372 Days
Time frame: up to 1 year
Number of Bleeding / Spotting Days by 90-day Reference Period
Time frame: up to 1 year
Number of Bleeding / Spotting Episodes in 90 Day Reference Period
Time frame: Up to one year
Days With Scheduled Versus Unscheduled Bleeding
Time frame: Up to one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22454004Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Long-term tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: results from a randomised, controlled, multicentre study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):84-93. doi: 10.1136/jfprhc-2011-100214.
- Results publication: PubMed 22454003Klipping C, Duijkers I, Fortier MP, Marr J, Trummer D, Elliesen J. Contraceptive efficacy and tolerability of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):73-83. doi: 10.1136/jfprhc-2011-100213.
- Results publication: PubMed 23493606Reif S, Snelder N, Blode H. Characterisation of the pharmacokinetics of ethinylestradiol and drospirenone in extended-cycle regimens: population pharmacokinetic analysis from a randomised Phase III study. J Fam Plann Reprod Health Care. 2013 Apr;39(2):e1-13. doi: 10.1136/jfprhc-2012-100397.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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
35 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 Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300), Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) and Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300) in people with Contraception, run by Bayer at 35 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 2 inclusion and 1 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 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany, Canada, Netherlands. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days With Bleeding Including Spotting (time frame: up to 1 year). The study lists 5 primary outcomes in all. 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 NCT00266032, which also lists 3 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 3 Nov 2014.