NCT01126801

Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This protocol is a controlled study of estradiol therapy in early postmenopausal women with and without frequent hot flashes that will be used to determine whether hot flashes are an important intermediary in the generation of menopause-associated depression.

Detailed description

SPECIFIC AIMS (Research Objectives) To define the relative effects of hot flashes and changes in estradiol on mood in postmenopausal women: Hypotheses: 1. Estrogen treatment has a similar therapeutic effect on mood in women with and without frequent hot flashes 2. Estradiol levels correlate with improvement in mood

Conditions

• Menopausal Depression

Interventions

Type	Name	Description
DRUG	Estradiol	Oral estradiol 1.0 mg/day for four weeks.
OTHER	Placebo control	Placebo control matched to estradiol tablets. Daily dosing for one month.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2010-05-20
• Last updated: 2017-10-20
• Results posted: 2016-08-22

Locations

1 site across 1 country: United States