MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and Venlafaxine XR for Treatment of Menopausal Symptoms
Condition: Hot Flashes; Menopause; Vasomotor Disturbance
MeSH terms: Hot Flashes
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): Low-dose 17-ß-estradiol with progesterone taper; Venlafaxine XR; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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).; 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).; The placebo is an inactive pill that looks like the active medication.
Other intervention name(s): The brand name of estradiol being used in this study is Estrace®.; The brand name of venlafaxine XR that is being used in this study is Effexor XR®
Intervention MeSH terms: Venlafaxine Hydrochloride; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Vasomotor; Symptoms; Estradiol; Venlafaxine