Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112138
Status:
COMPLETED
Last Update Posted:
2011-05-23
First Post:
2005-05-27
Brief Title:
Gabapentin for the Treatment of Hot Flashes in Menopausal Women
Sponsor:
North Toronto Primary Care Research Network
Organization:
North Toronto Primary Care Research Network
Study Overview
Official Title:
Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Health Canada CN 082818 | None | None | None |