Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
NCT02819921
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Adult Trials: 18+ Years
i. Women age 18 years and older with localized breast cancer. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A.
ii. Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed.
iii. History of bothersome hot flushes: ≥ 14 hot flushes/week (average ≥ 2 hot flushes/day), sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment.
i. Women who is pregnant or breast feeding, or who has a history of seizure disorder or
hepatic or renal insufficiency ii. Concurrent systemic hormone replacement therapy
(estrogen, progestational agents, androgens) or use of corticosteroids iii. Concurrent use
of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and
clonidine for treatment of hot flushes or depression.
iv. Presense or past history of severe psychiatric symptoms such as hallucinations and
delusions, manic episodes, or high suicide risk.
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| Descriptive Information | |||||||
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| Brief Title ICMJE | Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen | ||||||
| Official Title ICMJE | Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study | ||||||
| Brief Summary | This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Terminated | ||||||
| Actual Enrollment ICMJE | 59 | ||||||
| Original Estimated Enrollment ICMJE | 200 | ||||||
| Actual Study Completion Date ICMJE | June 15, 2019 | ||||||
| Actual Primary Completion Date | March 15, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: i. Women age 18 years and older with localized breast cancer. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A. ii. Current daily tamoxifen use (? 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed. iii. History of bothersome hot flushes: ? 14 hot flushes/week (average ? 2 hot flushes/day), sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment. Exclusion Criteria: i. Women who is pregnant or breast feeding, or who has a history of seizure disorder or hepatic or renal insufficiency ii. Concurrent systemic hormone replacement therapy (estrogen, progestational agents, androgens) or use of corticosteroids iii. Concurrent use of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and clonidine for treatment of hot flushes or depression. iv. Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk. | ||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02819921 | ||||||
| Other Study ID Numbers ICMJE | WI209149 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Seoul National University Hospital | ||||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Seoul National University Hospital | ||||||
| Verification Date | September 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||