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

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.

Conditions

• Hot Flashes
• Menopause
• Vasomotor Disturbance

Interventions

DRUG

Low-dose 17-ß-estradiol with progesterone taper

Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably. The 8 week estradiol treatment is followed by 14 days (2 weeks) of progesterone taper (as medroxy-progesterone 10 mg/day).

DRUG

Venlafaxine XR

Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).

DRUG

Placebo

The placebo is an inactive pill that looks like the active medication.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Office of Research on Women's Health (ORWH)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Andrea Z LaCroix, PhD · Fred Hutchinson Cancer Center

• Garnet Anderson, PhD · Fred Hutchinson Cancer Center

• Katherine Guthrie, PhD · Fred Hutchinson Cancer Center

• Lee S Cohen, MD · Massachusetts General Hospital/Harvard Medical School (HU)

• Hadine Joffe, MD, MSc · Massachusetts General Hospital/Harvard Medical School (HU)

• Katherine M Newton, PhD · Group Health Research Institute (GHRI)

• Susan D Reed, MD · University of Washington/Group Health Research Institute (GHRI)

• Janet Carpenter, PhD, RN, FAAN · Indiana University School of Medicine

• Ellen W Freeman, PhD · University of Pennsylvania School of Medicine (UP)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

62 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• United States

Study Locations