Status:
COMPLETED
MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hot Flashes
Menopause
Eligibility:
FEMALE
40-62 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine the efficacy of both low-dose oral (by mouth) 17-ß-estradiol and the non-hormonal drug venlafaxine XR compared to placebo in reducing hot flashes. I...
Detailed Description
The MsFLASH-03 study (Menopausal Strategies: Finding Lasting Answers for Symptoms and Health - 03), Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal S...
Eligibility Criteria
Inclusion
- Females aged 40-62 years
- Postmenopausal or perimenopausal
- Having bothersome hot flashes
- In general good health
- Signed informed consent
Exclusion
- Recent use of systemic hormone therapy or hormonal contraceptives
- Recent use of any prescribed, over-the-counter or herbal therapies that are taken specifically for hot flashes
- Recent use of selective estrogen receptor modulators (SERMS) or aromatase inhibitors
- Recent use of psychotropic medications, including SSRIs (selective serotonin reuptake inhibitors), serotonin-norepinephrine reuptake inhibitors (SNRIs), MAOIs (monoamine oxidase inhibitors), and other antidepressants and anxiolytics.
- Known hypersensitivity or contraindications (reasons not to take) to venlafaxine, estrogen, or progestins
- Not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period
- Recent drug or alcohol abuse
- Lifetime diagnosis of psychosis or bipolar disorder
- Suicide attempt in the past 3 years or any current suicidal ideation
- Current major depression (assessed during screening)
- Pregnancy, intending pregnancy, or breast feeding
- History of:
- Pre-breast cancer or high-risk breast cancer condition
- Abnormal bleeding suggestive of endometrial pre-cancer or endometrial hyperplasia
- Asthma, diabetes mellitus, epilepsy, and migraine disorders that are not stable or under medical management
- Abnormal screening blood tests
- Current participation in another drug trial or intervention study
- Inability or unwillingness to complete the study procedures
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT01418209
Start Date
November 1 2011
End Date
January 1 2013
Last Update
August 27 2014
Active Locations (4)
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1
Massachusetts General Hospital, Harvard Medical School (HU)
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02215
3
University of Pennsylvania, UP
Philadelphia, Pennsylvania, United States, 19104
4
Group Health Research Institute (GHRI)
Seattle, Washington, United States, 98101