Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

September 19, 2017 updated by: Hadine Joffe, MD, Massachusetts General Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women ≥40 years-old
  • Early postmenopausal, defined as:
  • No menstrual bleeding for 12-60 months secondary to natural menopause, according to STRAW criteria48
  • Hysterectomy without bilateral oophorectomy if surgery was completed after 6+ months of amenorrhea (no maximum duration of amenorrhea required)
  • Bilateral oophorectomy (no minimum or maximum duration of amenorrhea required)
  • Serum follicle-stimulating hormone (FSH) >25 IU/L and estradiol <20 pg/ml
  • Diagnosis of major depression on the MINI
  • Mild-to-moderate depressive symptoms, as indicated by MADRS score 15-31 and BDI score >15
  • Normal mammogram within the past 2 years
  • Good general health

Exclusion Criteria:

  • Severe depression, defined as a MADRS score >31, psychotic symptoms, or suicidal or homicidal ideation

  • Psychiatric illness, as defined by clinical interview and the Mini-International Neuropsychiatric Interview (MINI), as:

    • A lifetime history of bipolar disorder
    • A lifetime history of severe depression, as characterized by current or prior psychotic symptoms, inpatient psychiatric hospitalization or a suicide attempt in the previous 5 years, or
    • Current panic disorder or obsessive compulsive disorder
    • A lifetime history of psychotic symptoms
    • Current anorexia nervosa
    • An alcohol or substance-use disorder active within the past year
    • Current suicidal or homicidal ideation
  • Previous diagnosis of a sleep disorder (sleep apnea, PLMS, etc) or diagnosed on a screening PSG study
  • Pregnant, confirmed with serum ß-HCG at baseline (Visit 1)
  • Breastfeeding
  • Contraindication, hypersensitivity, or previous adverse reaction to E2 therapy
  • Current or recent (1 month) use of centrally active medications (antidepressants, anxiolytics, hypnotics, anticonvulsants, stimulants)
  • Current or recent (2 months) use of systemic hormone medications
  • History of breast cancer, premalignant breast lesions, or undiagnosed breast mass
  • Vaginal spotting or bleeding
  • History of thrombo-embolism, cardiovascular disease, congestive heart failure or other contraindication to estradiol therapy.
  • Liver dysfunction or disease
  • Renal insufficiency
  • Contraindications to progestin therapy
  • Asthma, diabetes mellitus, epilepsy, and migraine disorders that are not stable and under medical management
  • Other medical contraindications to estradiol and progestin therapy including porphyria, systemic lupus erythematosus, hepatic hemangiomas, deep vein thrombosis, hereditary angioedema, hypertriglyceridemia, severe Hypocalcemia.

  • Clinically significant abnormalities in screening blood tests including:

    • Thyroid-stimulating hormone <0.50 or >5.0 uU/mL)
    • Shift workers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control
Other: Placebo control
Placebo control matched to estradiol tablets. Daily dosing for one month.
Experimental: Estradiol
Drug: Estradiol
Oral estradiol 1.0 mg/day for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.
Time Frame: one month
one month

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009p001776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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