Endometrial HyperplasiaPhase 3NCT00242710

Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

A Phase 3 study testing Bazedoxifene/Conjugated Estrogen and CE 0.45 mg/MPA 1.5mg in people with Endometrial Hyperplasia and Osteoporosis, run by Pfizer at 9 sites in United States.

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

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women. Read more about this study

Who is it for?: Ages 40 to 65 years, women only
Conditions the study is for: Endometrial Hyperplasia, Osteoporosis
What is being tested?: Bazedoxifene/Conjugated Estrogen and CE 0.45 mg/MPA 1.5mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,083 participants
Where: 9 sitesUnited States
Study dates: Sep 2005to Sep 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 40 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Generally healthy, postmenopausal women, aged 40 to less than 65 years
Intact uterus
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL.

Who cannot join

Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
A history or active presence of clinically important medical disease
Malabsorption disorders

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Pfizer Investigational Site
Billings, Montana, 59102
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Eugene, Oregon, 97401
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Inverness, Florida, 34452
Pfizer Investigational Site
Lexington, Kentucky, 40536-0293
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15206
Pfizer Investigational Site
Upland, California, 91786
Pfizer Investigational Site
West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

Conditions: Endometrial Hyperplasia, Osteoporosis
Being tested: Bazedoxifene/Conjugated Estrogen, CE 0.45 mg/MPA 1.5mg, Placebo
Keywords: Endometrium, Uterus, Menopause
Medical subject headings: Endometrial Hyperplasia, Osteoporosis

What participants receive

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

Bazedoxifene/Conjugated EstrogenDrug
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Bazedoxifene/Conjugated EstrogenDrug
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
CE 0.45 mg/MPA 1.5mgDrug
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
PlaceboOther
Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Study groups in NCT00242710
Study group	Role	What they receive
1	Experimental	BZA 20mg/CE 0.625 Receives: Drug: Bazedoxifene/Conjugated Estrogen
Arm 2	Experimental	BZA 20mg/CE 0.45 Receives: Drug: Bazedoxifene/Conjugated Estrogen
Arm 3	Active comparator	CE 0.45mg/MPA1.5mg Receives: Drug: CE 0.45 mg/MPA 1.5mg
Arm 4	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

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

Percentage of Participants With Hyperplasia at Screening
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Measured: Screening
Percentage of Participants With Hyperplasia at Month 12
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Measured: Month 12
Bone Mineral Density (BMD) of Lumbar Spine at Screening
BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Measured: Screening
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12
BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Measured: Baseline, Month 12
Bone Mineral Density (BMD) of Total Hip at Screening
BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Measured: Screening
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12
BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Measured: Baseline, Month 12

Secondary outcomes (5)

Percentage of Days With Breast Pain
Percentage of days with breast pain in each 4-week period (for example, Week 1 to 4, 5 to 8) calculated as the number of days on which a participants reported breast pain divided by total number of days with data recorded multiplied by 100. Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.
Measured: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Uterine Bleeding or Spotting
Data was collected every day after randomization up to Year 1 and was analyzed in 4 weeks intervals. Data for screening was not analyzed since data were collected only for 7 days at screening which was not considered comparable to 4-week post-baseline data.
Measured: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Hyperplasia at Month 24
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Measured: Month 24
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24
BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Measured: Baseline, Month 24
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24
BMD measurements of the total hip were acquired by DXA, twice at Month 24 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Measured: Baseline, Month 24

Timeline

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

Sep 2005Sep 2008

First posted20 Oct 2005 (estimated)
Study startSep 2005
Primary completionSep 2008
Study completionSep 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 Endometrial HyperplasiaStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,083 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00242710
Sponsor's protocol ID: 3115A1-304
Status last verified: Oct 2013
First submitted: 18 Oct 2005
Last updated: 20 Dec 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

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RecruitingPhase 2
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All Endometrial Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo- And Active-Controlled Efficacy And Safety Study Of Bazedoxifene/Conjugated Estrogens Combinations For Prevention Of Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women
ClinicalTrials.gov ID: NCT00242710
Acronym / sponsor ID: 3115A1-304
Conditions: Endometrial Hyperplasia, Osteoporosis
Keywords: Endometrium, Uterus, Menopause
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,083 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 20 Oct 2005 (estimated)
Results: Posted 20 Dec 2013

Clinical summary

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

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Bazedoxifene/Conjugated EstrogenBZA 20mg/CE 0.625
Arm 2	Experimental	Drug: Bazedoxifene/Conjugated EstrogenBZA 20mg/CE 0.45
Arm 3	Active comparator	Drug: CE 0.45 mg/MPA 1.5mgCE 0.45mg/MPA1.5mg
Arm 4	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 40 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Generally healthy, postmenopausal women, aged 40 to less than 65 years
Intact uterus
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL.

Key exclusion criteria (3 listed)

Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
A history or active presence of clinically important medical disease
Malabsorption disorders

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
Bazedoxifene/Conjugated EstrogenSubjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.	Drug	1
Bazedoxifene/Conjugated EstrogenSubjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.	Drug	Arm 2
CE 0.45 mg/MPA 1.5mgSubjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.	Drug	Arm 3
PlaceboSubjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.	Other	Arm 4

Primary outcome

Percentage of Participants With Hyperplasia at Screening
Time frame: Screening
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Percentage of Participants With Hyperplasia at Month 12
Time frame: Month 12
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. Participants were considered to have a diagnosis of hyperplasia if both pathologists read hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia). If the both pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted, with the final diagnosis determined by the majority opinion.
Bone Mineral Density (BMD) of Lumbar Spine at Screening
Time frame: Screening
BMD measurements of the anteroposterior lumbar spine were acquired by dual-energy x-ray absorptiometry (DXA), twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12
Time frame: Baseline, Month 12
BMD measurements of the anteroposterior lumbar spine were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Bone Mineral Density (BMD) of Total Hip at Screening
Time frame: Screening
BMD measurements of the total hip were acquired by DXA, twice during screening in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 12
Time frame: Baseline, Month 12
BMD measurements of the total hip were acquired by DXA, twice at Month 12 in participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. An average of the 2 readings was reported.

5 secondary outcomes

Percentage of Days With Breast Pain
Time frame: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Uterine Bleeding or Spotting
Time frame: Screening, Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52
Percentage of Participants With Hyperplasia at Month 24
Time frame: Month 24
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 24
Time frame: Baseline, Month 24
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 24
Time frame: Baseline, Month 24

Results and safety

Results posted to the registry on 20 Dec 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
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg	373	287
Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg	353	289
Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg	183	132
Placebo	174	143

Primary outcome: Percentage of Participants With Hyperplasia at Screening

Time frame: Screening

Population analysed: Endometrial hyperplasia at screening was an exclusion criterion and participants who had hyperplasia were not included in the analysis. Therefore this data is not available.

Primary outcome: Percentage of Participants With Hyperplasia at Month 12

Time frame: Month 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg n = 261	Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg n = 273	Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg n = 119	Placebo n = 135
Value	0.00 (0.00 to 1.14)	1.10 (0.30 to 2.82)	0.00 (0.00 to 2.49)	0.00 (0.00 to 2.19)

Population analysed: Efficacy evaluable (EE) analysis population for Year 1: all participants who were randomized and took at least 1 dose of test article, who had a screening endometrial biopsy with readings by at least 2 blinded central pathologists, had a biopsy during Month 12, or had hyperplasia diagnosed before Month 12 and had no major protocol violations.

Primary outcome: Bone Mineral Density (BMD) of Lumbar Spine at Screening

Time frame: Screening. Mean (Standard Deviation). Unit: grams per square centimeter (g/cm^2)

Measure	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg n = 146	Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg n = 144	Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg n = 60	Placebo n = 65
Value	1.00 (0.12)	1.01 (0.12)	1.02 (0.12)	1.01 (0.12)

Population analysed: Modified intent-to-treat (MITT) population for BMD of lumber spine included all randomized participants took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after the test article administration was stopped were excluded) at Year 1.

Primary outcome: Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12

Time frame: Baseline, Month 12. Least squares mean (Standard Error). Unit: percent change

Measure	Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg n = 146	Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg n = 144	Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg n = 60	Placebo n = 65
Value	0.80 (0.24)	0.80 (0.24)	2.22 (0.37)	-1.56 (0.35)

Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg vs Placebo: Least Squares (LS) Mean Difference: 2.37 (95% CI 1.56 to 3.18), p <0.001, ANCOVA
Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg vs Placebo: LS Mean Difference: 2.36 (95% CI 1.56 to 3.17), p <0.001, ANCOVA
Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg vs Placebo: LS Mean Difference: 3.78 (95% CI 2.81 to 4.76), p <0.001, ANCOVA

Population analysed: MITT population for BMD of lumber spine: all randomized participants who took at least 1 dose of test article, and had a baseline and at least 1 on-therapy evaluation of BMD (scans acquired more than 60 days after test article administration was stopped were excluded) at Year 1. Missing values imputed using last observation carried forward (LOCF).

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg	22 of 361 (6.1%)	322 of 361 (89.2%)	Not reported
Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg	19 of 349 (5.4%)	309 of 349 (88.5%)	Not reported
Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg	7 of 179 (3.9%)	165 of 179 (92.2%)	Not reported
Placebo	7 of 172 (4.1%)	152 of 172 (88.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link 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.

Pfizer CT.gov Call Center study director

Pfizer

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bazedoxifene/Conjugated Estrogen and CE 0.45 mg/MPA 1.5mg in people with Endometrial Hyperplasia and Osteoporosis, run by Pfizer at 9 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 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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. 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?

Yes. Results are posted in the registry (first posted 20 Dec 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?

Percentage of Participants With Hyperplasia at Screening (time frame: Screening). The study lists 6 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 NCT00242710.

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 20 Dec 2013.