Hot FlashesPhase 3Breeze3NCT01080300

Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women

A Phase 3 study testing Gabapentin Extended Release in people with Hot Flashes, run by Depomed at 66 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

Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 600 participants
Where: 66 sitesUnited States
Study dates: Aug 2010to Sep 2011
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

Generally healthy, postmenopausal women who seek treatment for hot flashes
Patients using hormone replacement therapy(HRT) must be willing to discontinue treatment
Patients must be experiencing moderate to severe hot flashes
Patients must be able to sign the informed consent
Patients must be able to enter simple commands and complete questionnaires on the frequency and severity of their hot flashes using an electronic diary
Other inclusions apply.

Who cannot join

Patients with hypersensitivity to Gabapentin
Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss
Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
Patients currently treated with Gabapentin or Pregabalin for any indication, including vasomotor symptoms
Other exclusions apply.

Trial locations and contacts

66 sites in 1 country.

City, postcode or hospital

66 sites in 1 country

United States66 sites

Study site
Akron, Ohio
Study site
Albuquerque, New Mexico
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Anderson, South Carolina
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Berkeley, California
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Birmingham, Alabama
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Bismarck, North Dakota
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Brooklyn Center, Minnesota
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Brooksville, Florida
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Charlotte, North Carolina
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Charlottesville, Virginia
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Chattanooga, Tennessee
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Columbia, South Carolina
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Columbus, Ohio
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Dallas, Texas
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Danbury, Connecticut
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Decatur, Georgia
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DeLand, Florida
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Denver, Colorado
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Eugene, Oregon
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Fargo, North Dakota
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Gainesville, Florida
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Goose Creek, South Carolina
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Greer, South Carolina
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Kettering, Ohio
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Lake Jackson, Texas
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Las Vegas, Nevada
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Little Rock, Arkansas
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Louisville, Kentucky
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Milford, Connecticut
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Mobile, Alabama
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Moorestown, New Jersey
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Naples, Florida
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Nashville, Tennessee
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New Bern, North Carolina
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New Orleans, Louisiana
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New Port Richey, Florida
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North Miami, Florida
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Oklahoma City, Oklahoma
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Orlando, Florida
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Overland Park, Kansas
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Paw Paw, Michigan
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Plainsboro, New Jersey
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Raleigh, North Carolina
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Rapid City, South Dakota
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Reno, Nevada
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Richmond, Virginia
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Roseville, California
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Salt Lake City, Utah
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San Antonio, Texas
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San Diego, California
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Scottsdale, Arizona
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Seattle, Washington
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South Bend, Indiana
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Tucson, Arizona
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Warwick, Rhode Island
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West Reading, Pennsylvania
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Wexford, Pennsylvania
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Winston-Salem, North Carolina

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/Hot Flushes in postmenopausal women

Read the detailed description

The primary study objective is to assess the efficacy of G-ER dosed at 1800mg daily (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 at weeks 4 \& 12 of the efficacy treatment period, compared with baseline.

Conditions: Hot Flashes
Being tested: Gabapentin Extended Release, Placebo
Keywords: Hot Flushes, Vasomotor Symptoms, Menopausal Hot Flashes
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 ReleaseDrug
Gabapentin ER 1800mg daily
PlaceboDrug
Sugar pill

Study groups in NCT01080300
Study group	Role	What they receive
Gabapentin Extended Release	Experimental	Active treatment Receives: Drug: Gabapentin Extended Release
Placebo	Other	Placebo Receives: Drug: Placebo

What is being measured

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

G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.
G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.
Measured: Baseline, Week 4, and Week 12
G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.
G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.
Measured: Baseline, Week 4, and Week 12

Secondary outcomes (10)

G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.
G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 24 of the efficacy treatment period compared with Baseline.
Measured: Baseline, Week 24
G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.
G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 24 of the efficacy treatment period compared with Baseline.
Measured: Baseline, Week 24
Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Proportion of patients who were categorized as "very much" or "much improved" for PGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved".
Measured: Week 12 and Week 24
Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Proportion of patients who were categorized as "very much" or "much improved" in CGIC at Week 12 and Week 24. Scale range is 6 categories: "minimum value = very much worse" to "maximum value = very much improved".
Measured: Week 12 and Week 24
Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
Measured: Baseline, Week 12, and Week 24
Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes
Measured: Baseline, Week 12, and Week 24
Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference)
Measured: Baseline, Week 4, Week 12, and Week 24
Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period.
Insomnia Severity Index (ISI) scored on 4-point Likert-scales ('0' not at all - '4' extremely) for 7 sub-categories. Final score is sum of each sub-category generating a total sleep quality score (0-28). Minimum value = 0, maximum value = 28 (Lower scores indicate better outcome (ie, less severity)).
Measured: Baseline, Week 4, Week 12, and Week 24
Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period.
4 sub-categories each scored individually: Minimum value = 1, maximum value = 8.
Overall summary score was mean of the 4 sub-category scores (minimum = 1 and maximum = 8).
Lower scores indicate better outcome (ie, less severity)
Measured: Baseline, Week 4, Week 12, and Week 24
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects were classified as 0=no suicidal ideation or 1=suicidal ideation. Outcome Measure is number of participants with or without suicidal ideation.
Higher counts without suicidal ideation = better outcome.
Measured: Week 4, Week 12, Week 24/Early Termination, Week 28

Timeline

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

Aug 2010Sep 2011

First posted4 Mar 2010 (estimated)
Study startAug 2010
Primary completionSep 2011
Study completionSep 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.
Publications (1)Papers the sponsor has linked to this study.
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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01080300
Sponsor's protocol ID: 81-0064
Acronym: Breeze3
Status last verified: Apr 2020
First submitted: 2 Mar 2010
Last updated: 1 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pinkerton JV, Kagan R, Portman D, Sathyanarayana R, Sweeney M; Breeze 3 Investigators. Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause. 2014 Jun;21(6):567-73. doi: 10.1097/GME.0b013e3182a7c073.
PubMed 24149930

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 1 May 2020. 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: NCT01080300
Acronym / sponsor ID: Breeze3 / 81-0064
Conditions: Hot Flashes
Keywords: Hot Flushes, Vasomotor Symptoms, Menopausal Hot Flashes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: DepomedIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 4 Mar 2010 (estimated)
Results: Posted 26 Mar 2014

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/Hot Flushes in postmenopausal women

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Gabapentin Extended Release	Experimental	Drug: Gabapentin Extended ReleaseActive treatment
Placebo	Other	Drug: PlaceboPlacebo

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)

Generally healthy, postmenopausal women who seek treatment for hot flashes
Patients using hormone replacement therapy(HRT) must be willing to discontinue treatment
Patients must be experiencing moderate to severe hot flashes
Patients must be able to sign the informed consent
Patients must be able to enter simple commands and complete questionnaires on the frequency and severity of their hot flashes using an electronic diary

Key exclusion criteria (5 listed)

Patients with hypersensitivity to Gabapentin
Patients with severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS) or unexplained weight loss
Patients treated with estrogen pellets or injectable progestin drug therapy within 6 months.
Patients currently treated with Gabapentin or Pregabalin for any indication, including vasomotor symptoms
Other exclusions apply.

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 ReleaseGabapentin ER 1800mg daily	Drug	Gabapentin Extended Release
PlaceboSugar pill	Drug	Placebo

Primary outcome

G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.
Time frame: Baseline, Week 4, and Week 12
G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.
G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.
Time frame: Baseline, Week 4, and Week 12
G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as "Mild" (1), "Moderate" (2), and "Severe" (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline.

10 secondary outcomes

G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.
Time frame: Baseline, Week 24
G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.
Time frame: Baseline, Week 24
Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Time frame: Week 12 and Week 24
Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
Time frame: Week 12 and Week 24
Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
Time frame: Baseline, Week 12, and Week 24
Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes
Time frame: Baseline, Week 12, and Week 24
Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
Time frame: Baseline, Week 4, Week 12, and Week 24
Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period.
Time frame: Baseline, Week 4, Week 12, and Week 24
Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period.
Time frame: Baseline, Week 4, Week 12, and Week 24
Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: Week 4, Week 12, Week 24/Early Termination, Week 28

Results and safety

Results posted to the registry on 26 Mar 2014, 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 1800 mg	300	206
Sugar Pill	295	191

Primary outcome: G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.

Time frame: Baseline, Week 4, and Week 12. Least squares mean (95% Confidence Interval). Unit: hot flashes

Measure	G-ER 1800 mg n = 299	Sugar Pill n = 294
Baseline LOCF Average Daily Frequency at Week 4	-6.72 (-7.24 to -6.19)	-5.01 (-5.54 to -4.49)
Baseline LOCF Average Daily Frequency at Week 12	-7.64 (-8.21 to -7.07)	-6.50 (-7.07 to -5.94)

G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -1.70 (95% CI -2.31 to -1.09), p = 0.0003, Based on Van Eltereen
G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -1.14 (95% CI -1.80 to -0.48), p = 0.1000, Based on Van Elteren

Population analysed: Intent-to-treat (ITT) Population

Primary outcome: G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.

Time frame: Baseline, Week 4, and Week 12. Least squares mean (95% Confidence Interval). Unit: scores on a scale

Measure	G-ER 1800 mg n = 299	Sugar Pill n = 294
Baseline LOCF Average Daily Severity at Week 4	-0.42 (-0.51 to -0.33)	-0.22 (-0.31 to -0.13)
Baseline LOCF Average Daily Severity at Week 12	-0.65 (-0.77 to -0.52)	-0.46 (-0.58 to -0.34)

G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -0.21 (95% CI -0.31 to -0.10), p <0.0001, Based on Van Elteren
G-ER 1800 mg vs Sugar Pill: Mean Difference (Net): -0.19 (95% CI -0.33 to -0.04), p = 0.0004, Based on Van Elteren

Population analysed: Intent-to-treat (ITT) Population

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected for a total of 28-42 weeks: from after signing the informed consent to the end of the study (Week 28).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
G-ER 1800 mg	4 of 300 (1.3%)	102 of 300 (34%)	Not reported
Sugar Pill	7 of 295 (2.4%)	53 of 295 (18%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24149930Pinkerton JV, Kagan R, Portman D, Sathyanarayana R, Sweeney M; Breeze 3 Investigators. Phase 3 randomized controlled study of gastroretentive gabapentin for the treatment of moderate-to-severe hot flashes in menopause. Menopause. 2014 Jun;21(6):567-73. doi: 10.1097/GME.0b013e3182a7c073.

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.

Rekha Sathyanarayana study director

Depomed

66 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 in people with Hot Flashes, run by Depomed at 66 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 5 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 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 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 26 Mar 2014). 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?

G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline. (time frame: Baseline, Week 4, and Week 12). 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 NCT01080300, which also lists 1 linked publication.

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 1 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.