Effects of Estrogen and Hot Flashes on Mood in Postmenopausal Women
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
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 Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Menopausal Depression
Intervention
Estradiol, Placebo control
Location
Massachusetts General Hospital
Boston
Massachusetts
United States
02114
Status
Recruiting
Source
Massachusetts General Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01126801
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:34-0400
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Medical and Biotech [MESH] Definitions
Estradiol Congeners
Steroidal compounds related to ESTRADIOL, the major mammalian female sex hormone. Estradiol congeners include important estradiol precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with estrogenic activities.
Decompression
Decompression external to the body, most often the slow lessening of external pressure on the whole body (especially in caisson workers, deep sea divers, and persons who ascend to great heights) to prevent DECOMPRESSION SICKNESS. It includes also sudden accidental decompression, but not surgical (local) decompression or decompression applied through body openings.
Depression, Postpartum
Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386)
Dry Eye Syndromes
Corneal and conjunctival dryness due to deficient tear production, predominantly in menopausal and post-menopausal women. Filamentary keratitis or erosion of the conjunctival and corneal epithelium may be caused by these disorders. Sensation of the presence of a foreign body in the eye and burning of the eyes may occur.
Estradiol Antagonists
Compounds which inhibit or antagonize the biosynthesis or action of estradiol.
