Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen

NCT02819921

Last updated date
Study Location
National Cancer Center
Goyang, Gyeonggi-do, 10408, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hot Flashes, Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Hot Flashes, Breast NeoplasmsDesvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
NCT02819921
  1. Goyang, Gyeonggi-do
  2. Seongnam, Gyeonggi-do
  3. Seoul,
Female
19 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Hot Flashes
  • Breast Neoplasms
Intervention  ICMJE
  • Drug: Desvenlafaxine succinate 100mg
    Pristiq 100mg
  • Drug: Desvenlafaxine succinate 50mg
    Pristiq 50mg
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Desvenlafaxine succinate 100mg
    Titration with 50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 2 tablets of 50mg Desvenlafaxine succinate tablet once daily for 3 weeks, then taper with 50 mg Desvenlafaxine succinate tablet once daily for 3 days.
    Intervention: Drug: Desvenlafaxine succinate 100mg
  • Experimental: Desvenlafaxine succinate 50mg
    50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 1 tablets of 50mg Desvenlafaxine succinate tablet and 1 tablet of 50mg placebo tablet once daily for 3 weeks, then 50mg placebo tablet once daily for 3 days.
    Intervention: Drug: Desvenlafaxine succinate 50mg
  • Placebo Comparator: Placebo
    50 mg placebo tablet once daily for 1 week, then 2 tablets of 50mg placebo tablet once daily for 3 weeks, then 50 mg placebo tablet once daily for 3 days.
    Intervention: Drug: Placebo
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
 (submitted: September 18, 2019)
59
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
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
Sexes Eligible for Study:Female
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Seoul National University Bundang Hospital
  • Korea Cancer Center Hospital
  • Pfizer
Investigators  ICMJE
Principal Investigator:Bong-Jin Hahm, M.D., Ph.D.Seoul National University Hospital
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