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Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms

40 Years
62 Years
Not Enrolling
Hot Flashes, Menopause, Vasomotor Disturbance

Thank you

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

- 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:


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:


Principal Investigator

Andrea Z LaCroix, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

November 2011

Completion Date:

January 2013

Related Keywords:

  • Hot Flashes
  • Menopause
  • Vasomotor Disturbance
  • Menopause
  • Vasomotor
  • Symptoms
  • Estradiol
  • Venlafaxine
  • Hot Flashes



Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General Hospital, Harvard Medical School (HU)Boston, Massachusetts  02114
University of Pennsylvania, UPPhiladelphia, Pennsylvania  19104
Group Health Research Institute (GHRI)Seattle, Washington  98101