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Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

NCT01126801 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-10-20

Study results available
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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.

Conditions

  • Menopausal Depression

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Hadine Joffe, MD MSc · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01126801 on ClinicalTrials.gov