MF101, a selective estrogen receptor β modulator for the treatment of menopausal hot flushes: A phase II clinical trial

Deborah Grady; George F. Sawaya; Karen C. Johnson; William Koltun; Rachel Hess; Eric Vittinghoff; Margaret Kristof; Mary Tagliaferri; Isaac Cohen; Kristine E Ensrud

doi:10.1097/gme.0b013e31818e64dd

MF101, a selective estrogen receptor β modulator for the treatment of menopausal hot flushes: A phase II clinical trial

Deborah Grady, George F. Sawaya, Karen C. Johnson, William Koltun, Rachel Hess, Eric Vittinghoff, Margaret Kristof, Mary Tagliaferri, Isaac Cohen, Kristine E Ensrud

Medicine - Veteran's Administration Medical Center

Research output: Contribution to journal › Article › peer-review

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Abstract

OBJECTIVE: To determine the optimal dose, safety, and efficacy of an estrogen receptor β selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes. METHODS: A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks. RESULTS: The effects of 5 g/day of MF101 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03). CONCLUSIONS: Treatment with 10 g/day of MF101 reduces the frequency of hot flushes. Trials with higher doses are planned.

Original language	English (US)
Pages (from-to)	458-465
Number of pages	8
Journal	Menopause
Volume	16
Issue number	3
DOIs	https://doi.org/10.1097/gme.0b013e31818e64dd
State	Published - May 1 2009

Keywords

Estrogen receptor β selective estrogen
Hot flush

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title = "MF101, a selective estrogen receptor β modulator for the treatment of menopausal hot flushes: A phase II clinical trial",

abstract = "OBJECTIVE: To determine the optimal dose, safety, and efficacy of an estrogen receptor β selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes. METHODS: A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks. RESULTS: The effects of 5 g/day of MF101 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03). CONCLUSIONS: Treatment with 10 g/day of MF101 reduces the frequency of hot flushes. Trials with higher doses are planned.",

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AU - Grady, Deborah

AU - Sawaya, George F.

AU - Johnson, Karen C.

AU - Koltun, William

AU - Hess, Rachel

AU - Vittinghoff, Eric

AU - Kristof, Margaret

AU - Tagliaferri, Mary

AU - Cohen, Isaac

AU - Ensrud, Kristine E

PY - 2009/5/1

Y1 - 2009/5/1

N2 - OBJECTIVE: To determine the optimal dose, safety, and efficacy of an estrogen receptor β selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes. METHODS: A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks. RESULTS: The effects of 5 g/day of MF101 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03). CONCLUSIONS: Treatment with 10 g/day of MF101 reduces the frequency of hot flushes. Trials with higher doses are planned.

AB - OBJECTIVE: To determine the optimal dose, safety, and efficacy of an estrogen receptor β selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes. METHODS: A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks. RESULTS: The effects of 5 g/day of MF101 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03). CONCLUSIONS: Treatment with 10 g/day of MF101 reduces the frequency of hot flushes. Trials with higher doses are planned.

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KW - Hot flush

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MF101, a selective estrogen receptor β modulator for the treatment of menopausal hot flushes: A phase II clinical trial

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