Hot FlashesPhase 3NCT00777023

Study of Gabapentin Extended Release (G-ER)in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women.

A Phase 3 study testing Gabapentin Extended-Release (G-ER) 1200 mg and Gabapentin Extended-Release (G-ER) 1800 mg in people with Hot Flashes, run by Depomed at 45 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

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Hot Flashes
What is being tested?: Gabapentin Extended-Release (G-ER) 1200 mg and Gabapentin Extended-Release (G-ER) 1800 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 565 participants
Where: 45 sitesUnited States
Study dates: Oct 2008to Oct 2009
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 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal women aged 18 to 70 years experiencing ≥7 moderate to severe hot flashes per day (or ≥50 per week) accompanied by sweating during previous 30 days or longer.
Had amenorrhea for ≥12 months, amenorrhea for 6 to 12 months with serum follicle-stimulating hormone (FSH) levels >40 mIU/mL, or was ≥6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
Willing to discontinue the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; intrauterine progestin; progestin implants; injectable estrogen; topical progesterone cream.
Had to have daily average of ≥7 moderate to severe hot flashes and had to complete ≥4 days of diary entries during baseline week to be randomized.
If treated with antidepressants, could not have had any changes in drug doses during past month.
Other Inclusions apply.

Who cannot join

Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or aromatase inhibitors within 2 months prior to study entry.
Patient treated with estrogen pellets or progestin injectable drugs within 6 months prior to study entry.
Patient experience only nighttime hot flashes or worked night shifts on a regular basis.
Patient was concurrently treated with gabapentin for other indications. If patient was using gabapentin for treatment of hot flashes, she could be screened after a 7-day washout period provided hot flashes returned.
Patient had previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
Patient had a hypersensitivity to gabapentin.

Show all 14Show fewer

Patient was in an immunocompromised state.
Patient had a malignancy other than basal cell carcinoma within 2 years prior to study entry.
Patient had gastric reduction surgery, severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome, uncontrolled inflammatory bowel disease, or unexplained weight loss.
Patient had clinically significant abnormal chemistry or hematology results, or calculated glomerular filtration rate <60 mL/min.
Patient had history of substance abuse within year prior to study entry.
Patient was concurrently taking morphine.
Patient had history of chronic hepatitis B or C, hepatitis within 3 months prior to study entry, or history of human immunodeficiency virus.
Other Exclusions apply.

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, 30342
Radiant Research
Birmingham, Alabama, 35209
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501
Meridien Research
Bradenton, Florida, 34203
Meridien Research
Brooksville, Florida, 34601
Star W Research
Chandler, Arizona, 85225
Radiant Research, Inc.
Cincinnati, Ohio, 45249
Alpha Clinical Research, LLC
Clarksville, Tennessee, 37043
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
Columbus Center for Women's Health Research
Columbus, Ohio, 43213
Renaissance Clinical Research and Hypertension Clinic
Dallas, Texas, 75235
Danbury Clinical Research, LLC
Danbury, Connecticut, 06810
Atlanta West Women's Center
Douglasville, Georgia, 30134
Milestone Medical Research, Inc.
Englewood, Colorado, 80112
Clinical Trials of America, Inc.
Eugene, Oregon, 97401
Family Medical Center
Foothill Ranch, California, 92610
Southeastern Integrated Medical, PL
Gainsville, Florida, 32607
Upstate Pharmaceutical Research
Greenville, South Carolina, 29615
ActivMed Practices and Research
Haverhill, Massachusetts, 01830
Pinewest Ob-Gyn, Inc.
High Point, North Carolina, 27262
Physician's Research Group
Indianapolis, Indiana, 46250
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Clinical Research Investigative Services, LLC
Knoxville, Tennessee, 37923
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Sunrise Medical Research
Lauderdale Lakes, Florida, 33319
May Women's Health Clinic
Little Rock, Arkansas, 72205
West Bank Women's Health
Marrero, Louisiana, 70072
PMG/OB Gyn Health Center
Medford, Oregon, 97504
Mid-South OB-GYN, PLLC
Memphis, Tennessee, 38120
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Coastal Carolina Research Center, Inc.
Mt. Pleasant, South Carolina, 29464
Williamsburg Boro Park ObGyn, PC
New York, New York, 11211
Women's Health Care Specialists, PC
Paw Paw, Michigan, 49079
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Radiant Research - St. Petersburg
Pinellas Park, Florida, 33781
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604
Aspen Medical Group
Saint Paul, Minnesota, 55108
Radiant Research, Inc.
Salt Lake City, Utah, 84107
InVisions Consultants, LLC
San Antonio, Texas, 78217
Genesis Center for Clinical Research
San Diego, California, 92103
Study site
San Diego, California, 92103
Medical Center for Clinical Research
San Diego, California, 92108
Radiant Research
Scottsdale, Arizona, 85251
Advanced Clinical Research
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women

Read the detailed description

The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:

G-ER 1200mg daily (single evening dose)

G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg PM)

compared to placebo in reducing the average daily frequency and severity score of moderate to severe hot flashes in postmenopausal women after 4 weeks and 12 weeks of treatment with a stable dose, compared with the baseline week.

Conditions: Hot Flashes
Being tested: Gabapentin Extended-Release (G-ER) 1200 mg, Gabapentin Extended-Release (G-ER) 1800 mg, Placebo
Keywords: Hot Flashes, Hot Flushes, Postmenopausal symptoms, Vasomotor symptoms
Medical subject headings: Hot Flashes

What participants receive

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

Gabapentin Extended-Release (G-ER) 1200 mgDrug
Also called Gabapentin
G-ER 1200 mg daily dosage given as two 600-mg tablets.
Gabapentin Extended-Release (G-ER) 1800 mgDrug
Also called Gabapentin
G-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.
PlaceboDrug
Also called Placebo; sugar pill
Matching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).

Study groups in NCT00777023
Study group	Role	What they receive
G-ER 1200 mg	Experimental	Gabapentin extended-release (G-ER) 1200 mg Receives: Drug: Gabapentin Extended-Release (G-ER) 1200 mg
G-ER 1800 mg	Experimental	Gabapentin extended-release (G-ER) 1800 mg Receives: Drug: Gabapentin Extended-Release (G-ER) 1800 mg
Sugar Pill	Placebo comparator	Placebo 1200 mg or 1800 mg Receives: Drug: Placebo

What is being measured

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

Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Measured: At baseline and 4 weeks of treatment
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Measured: At baseline and 12 weeks of treatment
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
Measured: At baseline and 4 weeks of treatment
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.
Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
Measured: At baseline and 12 weeks of treatment

Timeline

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

Oct 2008Oct 2009

First posted22 Oct 2008 (estimated)
Study startOct 2008
Primary completionJul 2009
Study completionOct 2009

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 Hot FlashesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 565 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00777023
Sponsor's protocol ID: BREEZE 2
Other IDs: 81-0059
Status last verified: Feb 2012
First submitted: 21 Oct 2008
Last updated: 22 Feb 2012
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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All Hot Flashes trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
ClinicalTrials.gov ID: NCT00777023
Acronym / sponsor ID: BREEZE 2
Conditions: Hot Flashes
Keywords: Hot Flashes, Hot Flushes, Postmenopausal symptoms, Vasomotor symptoms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 565 participants (actual)
Lead sponsor: DepomedIndustry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Jul 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 17 Feb 2012

Clinical summary

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

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of gabapentin that is being studied for the treatment of hot flashes in postmenopausal women

Detailed description

The primary study objective is to assess the efficacy of G-ER dosed in either of the following regimens:

G-ER 1200mg daily (single evening dose)

G-ER 1800mg daily (dosed asymmetrically; 600mg AM/1200mg PM)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
G-ER 1200 mg	Experimental	Drug: Gabapentin Extended-Release (G-ER) 1200 mgGabapentin extended-release (G-ER) 1200 mg
G-ER 1800 mg	Experimental	Drug: Gabapentin Extended-Release (G-ER) 1800 mgGabapentin extended-release (G-ER) 1800 mg
Sugar Pill	Placebo comparator	Drug: PlaceboPlacebo 1200 mg or 1800 mg

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Postmenopausal women aged 18 to 70 years experiencing ≥7 moderate to severe hot flashes per day (or ≥50 per week) accompanied by sweating during previous 30 days or longer.
Had amenorrhea for ≥12 months, amenorrhea for 6 to 12 months with serum follicle-stimulating hormone (FSH) levels >40 mIU/mL, or was ≥6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
Willing to discontinue the following: vaginal hormonal products; transdermal or oral estrogen or estrogen/progestin combination; intrauterine progestin; progestin implants; injectable estrogen; topical progesterone cream.
Had to have daily average of ≥7 moderate to severe hot flashes and had to complete ≥4 days of diary entries during baseline week to be randomized.
If treated with antidepressants, could not have had any changes in drug doses during past month.

Key exclusion criteria (14 listed)

Patient treated with a gonadotrophin releasing hormone agonist, anti-estrogens, or aromatase inhibitors within 2 months prior to study entry.
Patient treated with estrogen pellets or progestin injectable drugs within 6 months prior to study entry.
Patient experience only nighttime hot flashes or worked night shifts on a regular basis.
Patient was concurrently treated with gabapentin for other indications. If patient was using gabapentin for treatment of hot flashes, she could be screened after a 7-day washout period provided hot flashes returned.
Patient had previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.

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
Gabapentin Extended-Release (G-ER) 1200 mgAlso: GabapentinG-ER 1200 mg daily dosage given as two 600-mg tablets.	Drug	G-ER 1200 mg
Gabapentin Extended-Release (G-ER) 1800 mgAlso: GabapentinG-ER 1800 mg daily dosage given as one 600-mg tablet in the morning and two 600-mg tablets in the evening.	Drug	G-ER 1800 mg
PlaceboAlso: Placebo; sugar pillMatching placebo dosages of 1200 mg daily (two 600-mg tablets) and 1800 mg daily (one 600-mg tablet in the morning and two 600-mg tablets in the evening).	Drug	Sugar Pill

Primary outcome

Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Time frame: At baseline and 4 weeks of treatment
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Time frame: At baseline and 12 weeks of treatment
Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
Time frame: At baseline and 4 weeks of treatment
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis. Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.
Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
Time frame: At baseline and 12 weeks of treatment
Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis. Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe.

Results and safety

Results posted to the registry on 17 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
G-ER 1200 mg	186	151
G-ER 1800 mg	190	149
Sugar Pill	183	146

Primary outcome: Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment

Time frame: At baseline and 4 weeks of treatment. Least squares mean (95% Confidence Interval). Unit: Hot flashes

Measure	G-ER 1200 mg n = 186	G-ER 1800 mg n = 190	Sugar Pill n = 183
Value	-7.0 (-7.77 to -6.19)	-6.9 (-7.68 to -6.08)	-5.4 (-6.18 to -4.46)

G-ER 1200 mg vs Sugar Pill: Mean Difference (Net): -1.61 (97.5% CI -2.80 to -0.42), p = 0.0024, ANCOVA
G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -1.51 (97.5% CI -2.69 to -0.33), p = 0.0040, ANCOVA

Population analysed: Intention to treat population

Primary outcome: Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment

Time frame: At baseline and 12 weeks of treatment. Least squares mean (95% Confidence Interval). Unit: Hot flashes

Measure	G-ER 1200 mg n = 186	G-ER 1800 mg n = 190	Sugar Pill n = 183
Value	-7.7 (-8.50 to -6.97)	-7.3 (-8.06 to -6.52)	-6.2 (-6.96 to -5.38)

G-ER 1200 mg vs Sugar Pill: Mean Difference (Net): -1.56 (97.5% CI -2.72 to -0.41), p = 0.0024, ANCOVA
G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -1.12 (97.5% CI -2.26 to 0.02), p = 0.0281, ANCOVA

Population analysed: Intent to treat population

Primary outcome: Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment

Time frame: At baseline and 4 weeks of treatment. Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	G-ER 1200 mg n = 186	G-ER 1800 mg n = 190	Sugar Pill n = 183
Value	-0.5 (-0.63 to -0.40)	-0.6 (-0.76 to -0.53)	-0.4 (-0.49 to -0.25)

G-ER 1200 mg vs Sugar Pill: Mean Difference (Net): -0.15 (97.5% CI -0.32 to -0.03), p = 0.0608, ANCOVA
G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -0.28 (97.5% CI -0.45 to -0.11), p = 0.0003, ANCOVA

Population analysed: Intent to treat population

Primary outcome: Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment

Time frame: At baseline and 12 weeks of treatment. Least squares mean (95% Confidence Interval). Unit: Units on a scale

Measure	G-ER 1200 mg n = 186	G-ER 1800 mg n = 190	Sugar Pill n = 183
Value	-0.8 (-0.90 to -0.61)	-0.8 (-0.97 to -0.68)	-0.5 (-0.69 to -0.39)

G-ER 1200 mg vs Sugar Pill: Mean Difference (Net): -0.21 (97.5% CI -0.43 to 0.00), p = 0.0280, ANCOVA
G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -0.29 (97.5% CI -0.51 to -0.07), p = 0.0026, ANCOVA

Population analysed: Intent to treat population

Adverse events

Time frame: Adverse events collected for total of 13 weeks: from baseline to end of stable dosing week (SDW) 12 (treatment Week 13; end-of-treatment period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
G-ER 1200 mg	2 of 186 (1.1%)	70 of 186 (37.6%)	Not reported
G-ER 1800 mg	2 of 190 (1.1%)	83 of 190 (43.7%)	Not reported
Sugar Pill	2 of 183 (1.1%)	29 of 183 (15.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hot Flashes

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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.

The record lists no contact. Use the official record to reach the sponsor.

45 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 Gabapentin Extended-Release (G-ER) 1200 mg and Gabapentin Extended-Release (G-ER) 1800 mg in people with Hot Flashes, run by Depomed at 45 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 6 inclusion and 14 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 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 17 Feb 2012). 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 in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment (time frame: At baseline and 4 weeks of treatment). The study lists 4 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 NCT00777023.

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 22 Feb 2012.