HemostasisPhase 2NCT01252186

A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

A Phase 2 study testing 91-day Levonorgestrel Oral Contraceptive, 28-day Levonorgestrel Oral Contraceptive and 28-day Desogestrel Oral Contraceptive in people with Hemostasis and Oral Contraceptive, run by Teva Women's Health at 24 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hemostasis, Oral Contraceptive
What is being tested?: 91-day Levonorgestrel Oral Contraceptive, 28-day Levonorgestrel Oral Contraceptive and 28-day Desogestrel Oral Contraceptive
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 265 participants
Where: 24 sitesin 2 countries
Study dates: Nov 2010to Dec 2011
Phase: Phase 2
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 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Premenopausal, non-pregnant, non-lactating women age 18-40 years old
Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
Regular spontaneous menstrual cycle
Others as dictated by FDA-approved protocol

Who cannot join

Any condition which contraindicates the use of combination oral contraceptives
Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
Others as dictated by FDA-approved protocol

Trial locations and contacts

24 sites in 2 countries.

Country

City, postcode or hospital

24 sites in 2 countries

United States21 sites

Teva Investigational Site
Albuquerque, New Mexico, 87102
Teva Investigational Site
Dallas, Texas, 75234
Teva Investigational Site
Edison, New Jersey, 08817
Teva Investigational Site
Houston, Texas, 77054
Teva Investigational Site
Miami, Florida, 33186
Teva Investigational Site
Philadelphia, Pennsylvania, 19114
Teva Investigational Site
Pittsburgh, Pennsylvania, 15206
Teva Investigational Site
Plainsboro, New Jersey, 08536
Teva Investigational Site
Port Jefferson, New York, 11777
Teva Investigational Site
Richmond, Virginia, 23233
Teva Investigational Site
Rochester, New York, 14609
Teva Investigational Site
San Antonio, Texas, 78258
Teva Investigational Site
San Diego, California, 92103
Teva Investigational Site
San Diego, California, 92108
Teva Investigational Site
San Diego, California, 92123
Teva Investigational Site
Sandy Springs, Georgia, 30328
Teva Investigational Site
Seattle, Washington, 98105
Teva Investigational Site
Uniontown, Pennsylvania, 15401
Teva Investigational Site
Washington D.C., District of Columbia, 20036
Teva Investigational Site
West Palm Beach, Florida, 33409
Teva Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Italy3 sites

Teva Investigational Site
Cagliari, 09124
Teva Investigational Site
Modena, 41100
Teva Investigational Site
Pavia, 27100

Other trials in Italy

About this study

Official title: A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-Day Extended Cycle Oral Contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women.

This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Conditions: Hemostasis, Oral Contraceptive
Being tested: 91-day Levonorgestrel Oral Contraceptive, 28-day Levonorgestrel Oral Contraceptive, 28-day Desogestrel Oral Contraceptive
Keywords: Contraception, Hemostasis, Blood Coagulation
Medical subject headings: Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

91-day Levonorgestrel Oral ContraceptiveDrug
Also called Seasonique®
91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
28-day Levonorgestrel Oral ContraceptiveDrug
Also called Minidril®
21 combination tablets containing 150 µg LNG/30 µg EE.
28-day Desogestrel Oral ContraceptiveDrug
Also called Marvelon®
21 combination tablets containing 150 µg DSG/30 µg EE.

Study groups in NCT01252186
Study group	Role	What they receive
91-day Levonorgestrel Oral Contraceptive	Experimental	Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. Receives: Drug: 91-day Levonorgestrel Oral Contraceptive
28-day Levonorgestrel Oral Contraceptive	Active comparator	Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. Receives: Drug: 28-day Levonorgestrel Oral Contraceptive
28-day Desogestrel Oral Contraceptive	Active comparator	Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. Receives: Drug: 28-day Desogestrel Oral Contraceptive

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.
Measured: Baseline to Month 6

Secondary outcomes (20)

Change From Baseline to End of Month 6 in D-dimer
D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex
The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)
The APC resistance assay is a clotting test that measures the ratio of APTT clotting times in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of the clotting time after APC addition over the clotting time with no APC addition.
APC resistance is defined as a poor anticoagulant response of plasma to APC (minimal prolongation of the APTT) and a correspondingly low ratio.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)
This assay is based on measurement of the effect of activated protein C on the endogenous thrombin potential, the time integral of thrombin generation initiated in plasma through the extrinsic coagulation pathway.
The APC resistance assay measures the ratio of endogenous thrombin potential in the presence and absence of a standard amount of exogenous APC.
APC resistance is calculated as the ratio of EPT after APC addition over the EPT with no APC addition.
APC resistance is defined as a poor anticoagulant response of plasma to APC (less inhibition of thrombin formation) and a correspondingly higher ratio.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Fibrinogen
Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Plasminogen
Plasminogen is the precursor of plasmin, which lyses fibrin clots.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)
Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Factor II
Clotting factor II, also called prothrombin, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Factor VII
Clotting factor VII, also called proconvertin or autoprothrombin I, functions in blood coagulation.
Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Factor VIII
Clotting factor VIII, also known as anti-hemophilic factor (AHF), functions in blood coagulation by stabilizing fibrin clots.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%.for adults.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Antithrombin
Antithrombin is a protein in the blood that naturally blocks blood clots from forming.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 80% to 130%.for adults.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Protein C Activity
Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% for adults.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Protein C Antigen
Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% in adults.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Free Protein S
Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with Protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Total Protein S
Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with activated protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting.
Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)
Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)
Measured: Baseline top Month 6
Change From Baseline to End of Month 6 in Total Cortisol
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin
Measured: Baseline to Month 6
Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)
Measured: Baseline to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Dec 2011

First posted2 Dec 2010 (estimated)
Study startNov 2010
Primary completionDec 2011
Study completionDec 2011

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.
Other trials for HemostasisStudies 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01252186
Sponsor's protocol ID: PSE-HSP-203
Other IDs: 2010-023215-34
Status last verified: Feb 2015
First submitted: 30 Nov 2010
Last updated: 13 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-Day Extended Cycle Oral Contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women.
ClinicalTrials.gov ID: NCT01252186
Acronym / sponsor ID: PSE-HSP-203
Conditions: Hemostasis, Oral Contraceptive
Keywords: Contraception, Hemostasis, Blood Coagulation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: Teva Women's HealthIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 2 Dec 2010 (estimated)
Results: Posted 13 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
91-day Levonorgestrel Oral Contraceptive	Experimental	Drug: 91-day Levonorgestrel Oral ContraceptiveParticipants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
28-day Levonorgestrel Oral Contraceptive	Active comparator	Drug: 28-day Levonorgestrel Oral ContraceptiveParticipants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
28-day Desogestrel Oral Contraceptive	Active comparator	Drug: 28-day Desogestrel Oral ContraceptiveParticipants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Premenopausal, non-pregnant, non-lactating women age 18-40 years old
Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²
Regular spontaneous menstrual cycle
Others as dictated by FDA-approved protocol

Key exclusion criteria (4 listed)

Any condition which contraindicates the use of combination oral contraceptives
Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening
Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
Others as dictated by FDA-approved protocol

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
91-day Levonorgestrel Oral ContraceptiveAlso: Seasonique®91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.	Drug	91-day Levonorgestrel Oral Contraceptive
28-day Levonorgestrel Oral ContraceptiveAlso: Minidril®21 combination tablets containing 150 µg LNG/30 µg EE.	Drug	28-day Levonorgestrel Oral Contraceptive
28-day Desogestrel Oral ContraceptiveAlso: Marvelon®21 combination tablets containing 150 µg DSG/30 µg EE.	Drug	28-day Desogestrel Oral Contraceptive

Primary outcome

Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels
Time frame: Baseline to Month 6
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.

20 secondary outcomes

Change From Baseline to End of Month 6 in D-dimer
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Fibrinogen
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Plasminogen
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Factor II
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Factor VII
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Factor VIII
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Antithrombin
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Protein C Activity
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Protein C Antigen
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Free Protein S
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Total Protein S
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)
Time frame: Baseline top Month 6
Change From Baseline to End of Month 6 in Total Cortisol
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin
Time frame: Baseline to Month 6
Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)
Time frame: Baseline to Month 6

Results and safety

Results posted to the registry on 13 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
91-day Levonorgestrel Oral Contraceptive	87	57
28-day Levonorgestrel Oral Contraceptive	91	59
28-day Desogestrel Oral Contraceptive	87	53

Primary outcome: Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels

Time frame: Baseline to Month 6. Least squares mean (Standard Error). Unit: pmol/L

Measure	91-day Levonorgestrel Oral Contraceptive n = 61	28-day Levonorgestrel Oral Contraceptive n = 67	28-day Desogestrel Oral Contraceptive n = 59
Value	169.53 (155.15)	157.99 (150.11)	592.29 (160.32)

91-day Levonorgestrel Oral Contraceptive vs 28-day Levonorgestrel Oral Contraceptive: Treatment Difference: -11.54 (95% CI -440.1 to 417.0), p = 0.958, Mixed Models Analysis
91-day Levonorgestrel Oral Contraceptive vs 28-day Desogestrel Oral Contraceptive: Treatment Difference: 422.76 (95% CI -18.3 to 863.8), p = 0.060, Mixed Models Analysis

Population analysed: Per-Protocol (PP) Population included all data from ITT participants obtained prior to experiencing major protocol violations.

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug until 14 days after the last dose (up to 27 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
91-day Levonorgestrel Oral Contraceptive	0 of 83 (0%)	16 of 83 (19.3%)	Not reported
28-day Levonorgestrel Oral Contraceptive	0 of 89 (0%)	10 of 89 (11.2%)	Not reported
28-day Desogestrel Oral Contraceptive	0 of 80 (0%)	17 of 80 (21.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Teva Women's Health Research Protocol Chair study chair

Teva Women's Health Research

24 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, 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 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?

Yes. Results are posted in the registry (first posted 13 Mar 2015). 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?

Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels (time frame: Baseline to Month 6). 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 NCT01252186.

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 13 Mar 2015.