Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women
NCT ID: NCT01126801
Last Updated: 2017-10-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2010-05-31
2011-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Estradiol
Estradiol
Oral estradiol 1.0 mg/day for four weeks.
Placebo control
Placebo control
Placebo control matched to estradiol tablets. Daily dosing for one month.
Interventions
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Estradiol
Oral estradiol 1.0 mg/day for four weeks.
Placebo control
Placebo control matched to estradiol tablets. Daily dosing for one month.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
FEMALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Hadine Joffe, MD
Vice Chair for Research, Psychiatry Department
Principal Investigators
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Hadine Joffe, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Galvan T, Camuso J, Sullivan K, Kim S, White D, Redline S, Joffe H. Association of estradiol with sleep apnea in depressed perimenopausal and postmenopausal women: a preliminary study. Menopause. 2017 Jan;24(1):112-117. doi: 10.1097/GME.0000000000000737.
Other Identifiers
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2009p001776
Identifier Type: -
Identifier Source: org_study_id