Breakthrough BleedingPhase 2NCT00394771

A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale

A Phase 2 study testing DR-1031, Seasonale® and Portia® in people with Breakthrough Bleeding, run by Duramed Research at 50 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breakthrough Bleeding
What is being tested?: DR-1031, Seasonale® and Portia®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 567 participants
Where: 50 sitesUnited States
Study dates: Oct 2006to Mar 2008
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 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Premenopausal
Not pregnant or breastfeeding
Agree to use back-up non-hormonal contraception for study period

Who cannot join

Any contraindication to the use of oral contraceptives
Pregnancy within the last 3 months
Smoking >10 cigarettes per day

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

United States50 sites

Duramed Investigational Site
Alpharetta, Georgia, 30005
Duramed Investigational Site
Austin, Texas, 78737
Duramed Investigational Site
Baton Rouge, Louisiana, 70808
Duramed Investigational Site
Boise, Idaho, 83712
Duramed Investigational Site
Cary, North Carolina, 27511
Duramed Investigational Site
Charleston, South Carolina, 29425
Duramed Investigational Site
Cleveland, Ohio, 44122
Duramed Investigational Site
Columbia, South Carolina, 29201
Duramed Investigational Site
Dallas, Texas, 75390
Duramed Investigational Site
DeLand, Florida, 32720
Duramed Investigational Site
Douglasville, Georgia, 30134
Duramed Investigational Site
Eugene, Oregon, 97401
Duramed Investigational Site
Fort Wayne, Indiana, 46825
Duramed Investigational Site
Hilton Head Island, South Carolina, 29926
Duramed Investigational Site
Houston, Texas, 77024
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Jackson, Tennessee, 38305
Duramed Investigational Site
Jacksonville, Florida, 32207
Duramed Investigational Site
Kansas City, Missouri, 64114
Duramed Investigational Site
Las Vegas, Nevada, 89109
Duramed Investigational Site
Las Vegas, Nevada, 89128
Duramed Investigational Site
Lebanon, New Hampshire, 03756
Duramed Investigational Site
Little Rock, Arkansas, 72205
Duramed Investigational Site
Mayfield Heights, Ohio, 44124
Duramed Investigational Site
Medford, Oregon, 97504
Duramed Investigational Site
Melbourne, Florida, 32935
Duramed Investigational Site
Meridian, Idaho, 83642
Duramed Investigational Site
Metairie, Louisiana, 70006
Duramed Investigational Site
Miami, Florida, 33186
Duramed Investigational Site
New Bern, North Carolina, 28562
Duramed Investigational Site
North Las Vegas, Nevada, 89030
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206
Duramed Investigational Site
Pueblo, Colorado, 81001
Duramed Investigational Site
Riverdale, Maryland, 20737
Duramed Investigational Site
Salt Lake City, Utah, 84102
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Diego, California, 92108
Duramed Investigational Site
San Francisco, California, 94102
Duramed Investigational Site
Santa Ana, California, 92705
Duramed Investigational Site
Savannah, Georgia, 31406
Duramed Investigational Site
Shreveport, Louisiana, 71106
Duramed Investigational Site
Stratford, Connecticut, 06615
Duramed Investigational Site
Tampa, Florida, 33607
Duramed Investigational Site
Tucson, Arizona, 85741
Duramed Investigational Site
Vista, California, 92083
Duramed Investigational Site
West Palm Beach, Florida, 33401
Duramed Investigational Site
West Palm Beach, Florida, 33407
Duramed Investigational Site
Wichita, Kansas, 67205
Duramed Investigational Site
Williston, Vermont, 05495
Duramed Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen

Read the detailed description

This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21 days after completion of study drug.

Conditions: Breakthrough Bleeding
Being tested: DR-1031, Seasonale®, Portia®
Keywords: oral contraceptives, breakthrough bleeding, spotting
Medical subject headings: Metrorrhagia

What participants receive

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

DR-1031Drug
Also called levonorgestrel/ethinyl estradiol, Quartette®
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
Seasonale®Drug
Also called levonorgestrel/ethinyl estradiol
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
Portia®Drug
Also called levonorgestrel/ethinyl estradiol
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.

Study groups in NCT00394771
Study group	Role	What they receive
Low Dose DR-1031	Experimental	42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. Receives: Drug: DR-1031; Drug: Portia®
Midrange Dose DR-1031	Experimental	21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. Receives: Drug: DR-1031; Drug: Portia®
High Dose DR-1031	Experimental	21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets. Receives: Drug: DR-1031; Drug: Portia®
Seasonale	Active comparator	84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets. Receives: Drug: Seasonale®; Drug: Portia®

What is being measured

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

Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Measured: Day 1-84
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Measured: Day 92-176

Secondary outcomes (10)

Days With Bleeding During Active Cycle 1 (Day 1-84)
Bleeding is defined as a flow heavy enough to require sanitary protection.
Measured: Day 1-84
Days With Bleeding During Active Cycle 2 (Day 92-176)
Bleeding is defined as a flow heavy enough to require sanitary protection.
Measured: Day 92-176
Time to First Bleeding Day
Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.
Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding.
Measured: Day 1-84
Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)
Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.
Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.
See pre-specified analyses for Number of Moderate to Heavy Bleeding Days.
Measured: Day 1-84
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.
Measured: Day 85-91
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.
Measured: Day 177-183
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Measured: Day 1-84
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Measured: Day 92-176
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Measured: Day 85-91
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
Measured: Day 177-183

Timeline

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

Oct 2006Mar 2008

First posted1 Nov 2006 (estimated)
Study startOct 2006
Primary completionMar 2008
Study completionMar 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.
Other trials for Breakthrough BleedingStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 567 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00394771
Sponsor's protocol ID: DR-ASC-201
Status last verified: Jul 2013
First submitted: 30 Oct 2006
Last updated: 26 Jul 2013
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

Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
RecruitingObservational study
A Study on Abnormal Menstrual Bleeding in Chinese Women of Childbearing Age Taking Antithrombotic Drugs After Cardiovascular Surgery
Uterine Hemorrhage, Cardiovascular Diseases
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer

All Breakthrough Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen
ClinicalTrials.gov ID: NCT00394771
Acronym / sponsor ID: DR-ASC-201
Conditions: Breakthrough Bleeding
Keywords: oral contraceptives, breakthrough bleeding, spotting
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 567 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 1 Nov 2006 (estimated)
Results: Posted 19 Jun 2013

Clinical summary

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

Detailed description

Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Low Dose DR-1031	Experimental	Drug: DR-1031, Drug: Portia®42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
Midrange Dose DR-1031	Experimental	Drug: DR-1031, Drug: Portia®21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
High Dose DR-1031	Experimental	Drug: DR-1031, Drug: Portia®21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
Seasonale	Active comparator	Drug: Seasonale®, Drug: Portia®84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Premenopausal
Not pregnant or breastfeeding
Agree to use back-up non-hormonal contraception for study period

Key exclusion criteria (3 listed)

Any contraindication to the use of oral contraceptives
Pregnancy within the last 3 months
Smoking >10 cigarettes per day

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
DR-1031Also: levonorgestrel/ethinyl estradiol, Quartette®Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.	Drug	High Dose DR-1031, Low Dose DR-1031, Midrange Dose DR-1031
Seasonale®Also: levonorgestrel/ethinyl estradiol84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.	Drug	Seasonale
Portia®Also: levonorgestrel/ethinyl estradiolPortia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.	Drug	High Dose DR-1031, Low Dose DR-1031, Midrange Dose DR-1031, Seasonale

Primary outcome

Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
Time frame: Day 1-84
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
Time frame: Day 92-176
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.

10 secondary outcomes

Days With Bleeding During Active Cycle 1 (Day 1-84)
Time frame: Day 1-84
Days With Bleeding During Active Cycle 2 (Day 92-176)
Time frame: Day 92-176
Time to First Bleeding Day
Time frame: Day 1-84
Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)
Time frame: Day 1-84
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
Time frame: Day 85-91
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183)
Time frame: Day 177-183
Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84)
Time frame: Day 1-84
Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176)
Time frame: Day 92-176
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91)
Time frame: Day 85-91
Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183)
Time frame: Day 177-183

Results and safety

Results posted to the registry on 19 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose DR-1031	140	99
Midrange Dose DR-1031	136	102
High Dose DR-1031	143	96
Seasonale	148	109

Primary outcome: Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)

Time frame: Day 1-84. Median (Full Range). Unit: days

Measure	Low Dose DR-1031 n = 110	Midrange Dose DR-1031 n = 110	High Dose DR-1031 n = 108	Seasonale n = 120
Value	13 (0 to 67)	13.5 (0 to 65)	15 (0 to 69)	15 (0 to 56)

Population analysed: Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary.

Primary outcome: Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)

Time frame: Day 92-176. Median (Full Range). Unit: days

Measure	Low Dose DR-1031 n = 109	Midrange Dose DR-1031 n = 108	High Dose DR-1031 n = 107	Seasonale n = 120
Value	6 (0 to 74)	7 (0 to 70)	5 (0 to 74)	6 (0 to 55)

Population analysed: Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 256 (longest treatment plus 14 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose DR-1031	1 of 140 (0.7%)	61 of 140 (43.6%)	Not reported
Midrange Dose DR-1031	2 of 136 (1.5%)	44 of 136 (32.4%)	Not reported
High Dose DR-1031	3 of 143 (2.1%)	49 of 143 (34.3%)	Not reported
Seasonale	5 of 148 (3.4%)	53 of 148 (35.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breakthrough Bleeding

Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
RecruitingObservational study
A Study on Abnormal Menstrual Bleeding in Chinese Women of Childbearing Age Taking Antithrombotic Drugs After Cardiovascular Surgery
Uterine Hemorrhage, Cardiovascular Diseases
Active, not recruitingObservational study
Endometrial Cancer Vaginal Fluid Specimen Collection Study
Abnormal Uterine Bleeding (AUB), Endometrial Cancer

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.

Duramed Medical Monitor principal investigator

Duramed Research

50 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DR-1031, Seasonale® and Portia® in people with Breakthrough Bleeding, run by Duramed Research at 50 sites in United States.

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 3 inclusion and 3 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 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. 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 19 Jun 2013). 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?

Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) (time frame: Day 1-84). The study lists 2 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 NCT00394771.

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 26 Jul 2013.