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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01126801 |
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Date of registration:
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11/05/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women
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Scientific title:
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Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01126801 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Hadine Joffe, MD MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Brigham and Women's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Menopausal Depression
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Intervention(s)
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Other: Placebo control
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Drug: Estradiol
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Primary Outcome(s)
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Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.
[Time Frame: one month]
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Secondary Outcome(s)
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Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.
[Time Frame: one month]
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Secondary ID(s)
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2009p001776
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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