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Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01126801
Recruitment Status : Terminated (Stopped enrolling subjects due to challenge of identifying eligible participants)
First Posted : May 20, 2010
Results First Posted : August 22, 2016
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Menopausal Depression Drug: Estradiol Other: Placebo control Phase 2

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  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011


Arm Intervention/treatment
Experimental: Estradiol Drug: Estradiol
Oral estradiol 1.0 mg/day for four weeks.

Placebo Comparator: Placebo control Other: Placebo control
Placebo control matched to estradiol tablets. Daily dosing for one month.




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

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126801


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Hadine Joffe, MD MSc Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hadine Joffe, MD, Vice Chair for Research, Psychiatry Department, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01126801     History of Changes
Other Study ID Numbers: 2009p001776
First Posted: May 20, 2010    Key Record Dates
Results First Posted: August 22, 2016
Last Update Posted: October 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female