Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women

NCT01126801 | Terminated Phase 2 Results DMC

• 1 other identifier: 2009p001776
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal Depression

Outcome Measures

Primary Outcomes (1)

• Improvement of Mood, Measured by the Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to Study End.

  one month

Secondary Outcomes (1)

• Improvement of Mood, Measured by the Self-rated Beck Depression Inventory (BDI) From Baseline to Study End.

  one month

Study Arms (2)

Estradiol

EXPERIMENTAL

Drug: Estradiol

Placebo control

PLACEBO COMPARATOR

Other: Placebo control

Interventions

Estradiol DRUG

Oral estradiol 1.0 mg/day for four weeks.

Estradiol

Placebo control OTHER

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

Placebo control

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 27648659 DERIVED

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Due to the challenge of identifying eligible participants, we decided to stop enrolling subjects and not to analyze the 2 completed participants.

Results Point of Contact

• Title: Dr. Hadine Joffe
• Organization: Brigham & Women's Hospital

hjoffe@partners.org

617-732-4906

Study Officials

• Hadine Joffe, MD MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Research, Psychiatry Department

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 20, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 20, 2017
• Results First Posted: August 22, 2016

Record last verified: 2017-09

Locations

US (1)