Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms
40 Years
62 Years
Female
Hot Flashes, Menopause, Vasomotor Disturbance
Trial Information
Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms
The MsFLASH-03 study, Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR
for Treatment of Menopausal Symptoms, is a randomized, double-blind, placebo-controlled,
three arm clinical trial. The design includes: 3 weeks of daily recording of hot flashes
prior to drug treatment; 8 weeks of double-blind treatment with oral estradiol, venlafaxine,
or placebo; followed by 14 days of drug taper for those on venlafaxine and 14 days of
progesterone treatment for those on estradiol; followed by 2 weeks with no treatment for all
groups; and a telephone follow-up post-treatment.
Inclusion Criteria:
- Females aged 40-62 years
- Postmenopausal or perimenopausal
- Having bothersome hot flashes
- In general good health
- Signed informed consent
Exclusion Criteria:
- 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), SNRIs (serotonin-norepinephrine reuptake inhibitors), 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Frequency of hot flashes
Outcome Description:
Measured by self-report diary twice daily for 7 days
Outcome Time Frame:
8 weeks
Safety Issue:
No
Principal Investigator
Andrea Z LaCroix, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
MsFLASH-03
NCT ID:
NCT01418209
Start Date:
November 2011
Completion Date:
January 2013
Related Keywords:
- Hot Flashes
- Menopause
- Vasomotor Disturbance
- Menopause
- Vasomotor
- Symptoms
- Estradiol
- Venlafaxine
- Hot Flashes
Name | Location |
|---|---|
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Massachusetts General Hospital, Harvard Medical School (HU) | Boston, Massachusetts 02114 |
| University of Pennsylvania, UP | Philadelphia, Pennsylvania 19104 |
| Group Health Research Institute (GHRI) | Seattle, Washington 98101 |
