CompletedNot Applicable

Effect of DT56a (Femarelle) on the Coagulation System in the Treatment of Postmenopausal Women

United States32 participantsStarted 2007-01

Plain-language summary

The purpose of this study is to determine if Femeralle (DT56a) has an effect on the coagulation system, measured by platelet adhesion and aggregation, of normal and thrombophilic postmenopausal women.

Who can participate

Age range40 Years

SexFEMALE

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Inclusion Criteria: * No previous exogenous estrogen exposure * Symptomatic Menopause: hot flashes, sleep disturbance, or other symptoms related to estrogen deficiency * Menopausal (see above) Exclusion Criteria: * History of bleeding or thrombotic disorder * History of malignancy (particularly Breast Cancer) * Diabetics * Coronary Artery Disease * Liver Disease * Concurrent Anticoagulation therapy

What they're measuring

The PFA-100 (Dade Behring, Inc.) device was used to evaluate platelet adhesion and aggregation. Clotting time (sec.) was recorded and defined as the time for blood to block a collagen membrane coated with epinephrine (CEPI) or ADP (CADP).

Timeframe: 1 year

Trial details

NCT IDNCT00883272

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-01

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