Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363909
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2006-08-10
Brief Title:
Citalopram in Treating Postmenopausal Women With Hot Flashes
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Randomized Double-Blind Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes
Status:
COMPLETED
Status Verified Date:
2016-12
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:
RATIONALE Citalopram may help relieve hot flashes in women who had or have not had breast cancer It is not yet known which dose of citalopram is more effective in treating hot flashes in postmenopausal women
PURPOSE This randomized phase III trial is studying three different doses of citalopram to compare how well they work in treating postmenopausal women with hot flashes
PURPOSE This randomized phase III trial is studying three different doses of citalopram to compare how well they work in treating postmenopausal women with hot flashes
Detailed Description:
OBJECTIVES
Primary
Evaluate the efficacy of three different doses of citalopram hydrobromide on hot flash scores in postmenopausal women with a history of breast cancer or in postmenopausal women who do not wish to take estrogen replacement therapy for fear of increased risk of breast cancer
Secondary
Compare the side effect profile of these regimens in these patients
Compare the effects of these regimens on the secondary outcome of mood and interference with activities from hot flashes
Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of citalopram hydrobromide
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 18-49 years vs 50 years tamoxifen yes vs no selective estrogen-receptor modulators SERMs yes vs no aromatase inhibitors yes vs no duration of hot flashes 9 months vs 9 months and frequency of hot flashes per day 4 vs 4-9 vs 10 Patients are randomized to 1 of 4 treatment arms
Arm I low-dose citalopram hydrobromide Patients receive 1 tablet of oral citalopram once daily in weeks 2-7
Arm II medium-dose citalopram hydrobromide Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7
Arm III high-dose citalopram hydrobromide Patients receive 1 tablet of oral citalopram once daily in week 2 2 tablets once daily in week 3 and 3 tablets once daily in weeks 4-7
Arm IV placebo Patients receive 1-3 placebo tablets once daily in weeks 2-7 All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies
A Symptom Experience diary is completed weekly and Profile of Mood States and Hot Flash-Related Interference Scale questionnaires are completed at baseline and in week 7
Primary
Evaluate the efficacy of three different doses of citalopram hydrobromide on hot flash scores in postmenopausal women with a history of breast cancer or in postmenopausal women who do not wish to take estrogen replacement therapy for fear of increased risk of breast cancer
Secondary
Compare the side effect profile of these regimens in these patients
Compare the effects of these regimens on the secondary outcome of mood and interference with activities from hot flashes
Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of citalopram hydrobromide
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 18-49 years vs 50 years tamoxifen yes vs no selective estrogen-receptor modulators SERMs yes vs no aromatase inhibitors yes vs no duration of hot flashes 9 months vs 9 months and frequency of hot flashes per day 4 vs 4-9 vs 10 Patients are randomized to 1 of 4 treatment arms
Arm I low-dose citalopram hydrobromide Patients receive 1 tablet of oral citalopram once daily in weeks 2-7
Arm II medium-dose citalopram hydrobromide Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7
Arm III high-dose citalopram hydrobromide Patients receive 1 tablet of oral citalopram once daily in week 2 2 tablets once daily in week 3 and 3 tablets once daily in weeks 4-7
Arm IV placebo Patients receive 1-3 placebo tablets once daily in weeks 2-7 All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies
A Symptom Experience diary is completed weekly and Profile of Mood States and Hot Flash-Related Interference Scale questionnaires are completed at baseline and in week 7
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 |
|---|---|---|---|
| CDR0000489567 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02699 | REGISTRY | None | None |