N/A N=339 Randomized Quadruple-blind Treatment

MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms

Hot Flashes · Menopause · Vasomotor Disturbance

Bottom Line

View on ClinicalTrials.gov: NCT01418209 ↗

Enrolled (actual)

339

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4 — 5.3; 5.1; 5.8 number of hot flashes per day

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Low-dose 17-ß-estradiol with progesterone taper (Drug); Venlafaxine XR (Drug); Placebo (Drug)
Age: Adult · 40+ yrs
Sex: Female
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4	5.3; 5.1; 5.8	—
PRIMARY Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8	3.9; 4.4; 5.5	<0.001 sig
SECONDARY Severity of Hot Flashes -- Week 4	0.7; 0.7; 0.8	—
SECONDARY Severity of Hot Flashes -- Week 8	0.6; 0.6; 0.7	0.02 sig
SECONDARY Bothersomeness of Hot Flashes -- Week 4	1.6; 1.6; 1.7	—
SECONDARY Bothersomeness of Hot Flashes -- Week 8	1.4; 1.4; 1.6	0.01 sig
SECONDARY Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4	18.3; 19.8; 24.2	—
SECONDARY Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8	14.6; 18.3; 21.5	<0.001 sig

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. Included in this objective is the intention to compare venlafaxine XR to estradiol therapy, to provide evidence of the relative efficacy of venlafaxine to what is currently considered the most established but also a controversial therapy. 17-ß-estradiol is a type of estrogen. Venlafaxine XR is the extended release (XR) version of venlafaxine. Venlafaxine XR is an serotonin-norepinephrine reuptake inhibitor (SNRI). A placebo is a substance containing no medication.

Eligibility Criteria

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), 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01418209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.