Hot FlashesPhase 3NCT00112138
Gabapentin for the Treatment of Hot Flashes in Menopausal Women
A Phase 3 study testing gabapentin in people with Hot Flashes and Menopause, run by North Toronto Primary Care Research Network at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized controlled trial. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Menopause
- What is being tested?
- gabapentin
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2004to Feb 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with substantial hot flashes defined as reporting at least 14 hot flashes per week.
- Postmenopausal women as defined by the natural cessation of menses for 1 year.
- Aged 45 - 65 years.
Who cannot join
- Women on hormone replacement therapy.
- Women with a surgically induced menopause (oophorectomy).
- Women on tamoxifen or receiving chemotherapy/radiation therapy or planned antineoplastic chemotherapy/radiation therapy.
- Renal function impairment (serum creatinine greater than the laboratory normal range; or creatinine clearance <30ml/min).
- Use of antidepressants with serotonin reuptake mechanisms and antiseizure medications within the past month.
- Neurologic conditions: seizures, vertigo, and syncope.
Show all 10Show fewer
- Known hypersensitivity to gabapentin and its components.
- Inability to complete questionnaires for any reason including psychiatric disorders.
- History of a hypothalamic dysfunction.
- Life expectancy less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized controlled trial.
Read the detailed description
For women who fear developing breast cancer, those who have contraindications to hormone replacement therapy and those who prefer an alternative treatment, there is presently no standard treatment for hot flashes. Women and health care providers have few options other than hormone replacement therapy as evidenced-based trials of alternatives have not shown many effective options. Many non-hormonal agents have been studied including antidepressants, antihypertensives, vitamin E, soy products, black cohosh, acupuncture, and belladonna and ergotamine combinations. Preliminary studies using the antiseizure medication, gabapentin (Neurontin), has demonstrated a substantial reduction in hot flashes. This agent may provide an effective treatment for hot flashes in postmenopausal women.
- Conditions
- Hot Flashes, Menopause
- Being tested
- gabapentin
- Keywords
- gabapentin, hot flashes or flushes, menopause
- Medical subject headings
- Hot Flashes, Blushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
Secondary outcomes (3)
The toxicity profile of gabapentin in this population compared with placebo
The impact of gabapentin on quality of life in this population compared with placebo
Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2005 (estimated)
- Study startMar 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- North Toronto Primary Care Research Network
- Sponsor type
- Research network
- Investigators
- Debra Butt, MSc MD CCFP, Principal investigator, North Toronto Primary Care Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112138
- Sponsor's protocol ID
- 03-19
- Other IDs
- Health Canada: CN 082818
- Status last verified
- May 2011
- First submitted
- 27 May 2005
- Last updated
- 23 May 2011
- Results posted
- No
Publications
Guttuso T Jr, Kurlan R, McDermott MP, Kieburtz K. Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):337-45. doi: 10.1016/s0029-7844(02)02712-6.
PubMed 12576259
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00112138
- Acronym / sponsor ID
- 03-19
- Conditions
- Hot Flashes, Menopause
- Keywords
- gabapentin, hot flashes or flushes, menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- North Toronto Primary Care Research NetworkResearch network
- Study start
- Mar 2004
- Study completion
- Feb 2006
- First posted
- 30 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and safety of gabapentin compared to placebo in the treatment of hot flashes in postmenopausal women using a phase III randomized controlled trial.
Detailed description
For women who fear developing breast cancer, those who have contraindications to hormone replacement therapy and those who prefer an alternative treatment, there is presently no standard treatment for hot flashes. Women and health care providers have few options other than hormone replacement therapy as evidenced-based trials of alternatives have not shown many effective options. Many non-hormonal agents have been studied including antidepressants, antihypertensives, vitamin E, soy products, black cohosh, acupuncture, and belladonna and ergotamine combinations. Preliminary studies using the antiseizure medication, gabapentin (Neurontin), has demonstrated a substantial reduction in hot flashes. This agent may provide an effective treatment for hot flashes in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with substantial hot flashes defined as reporting at least 14 hot flashes per week.
- Postmenopausal women as defined by the natural cessation of menses for 1 year.
- Aged 45 - 65 years.
Key exclusion criteria (10 listed)
- Women on hormone replacement therapy.
- Women with a surgically induced menopause (oophorectomy).
- Women on tamoxifen or receiving chemotherapy/radiation therapy or planned antineoplastic chemotherapy/radiation therapy.
- Renal function impairment (serum creatinine greater than the laboratory normal range; or creatinine clearance <30ml/min).
- Use of antidepressants with serotonin reuptake mechanisms and antiseizure medications within the past month.
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 | Drug | – |
Primary outcome
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women
3 secondary outcomes
The toxicity profile of gabapentin in this population compared with placebo
The impact of gabapentin on quality of life in this population compared with placebo
Correlation of the Menopause-specific Quality of Life (MENQOL) results with the change in hot flash scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2011.
- Background: PubMed 12576259Guttuso T Jr, Kurlan R, McDermott MP, Kieburtz K. Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):337-45. doi: 10.1016/s0029-7844(02)02712-6.
Related trials for Hot Flashes
RecruitingPhase 2/3
Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
Menopause, Menopause Hot Flashes
RecruitingPhase 3
A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause
Hot Flashes
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast 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.
Debra Butt, MSc MD CCFP principal investigator
North Toronto Primary Care Research Network
1 site 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 in people with Hot Flashes and Menopause, run by North Toronto Primary Care Research Network at 1 site in Canada.
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 10 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 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compared to placebo, gabapentin effectiveness in reducing hot flash scores in postmenopausal women. 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 NCT00112138, 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 23 May 2011.