Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes
I. To evaluate the impact of SAMe on hot flash scores in women with a history of breast
cancer or women who do not wish to take estrogen therapy for fear of increased risk of
II. To evaluate the toxicity of SAMe in this study population. III. To evaluate the effect
of SAMe using quality-of-life (QOL) measures.
During the first week, participants will complete a daily, prospective hot flash diary and
complete baseline questionnaires and will not be taking any study medication. After this
baseline week, participants will receive oral s-adenosyl-L-methionine, 400 mg, once daily on
days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Reduction in average hot flash activity score (severity and frequency)
From baseline to week 7
Amit Sood, M.D.
United States: Institutional Review Board
|Mayo Clinic||Rochester, Minnesota 55905|