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Pharmaceuticals 2012, 5(9), 899-924; doi:10.3390/ph5090899
Review

The Tissue Selective Estrogen Complex: A Promising New Menopausal Therapy

*  and
Received: 2 July 2012; in revised form: 18 August 2012 / Accepted: 24 August 2012 / Published: 4 September 2012
(This article belongs to the Special Issue Hormone Therapy)
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Abstract: Menopause is associated with health concerns including vasomotor symptoms, vulvar/vaginal atrophy (VVA), and osteoporosis. Estrogen therapy or combined estrogen-progestin therapy (EPT) are primary treatment options for menopausal symptom relief and osteoporosis prevention. Because EPT has been associated with some safety/tolerability concerns relating to undesirable effects of estrogen and progestin, alternative options are needed. The tissue selective estrogen complex (TSEC) is a novel class of agents pairing a selective estrogen receptor modulator (SERM) with 1 or more estrogens. The TSEC combines the established efficacy of estrogens on menopausal symptoms and bone with the protective effects of a SERM on the reproductive tract. The pairing of bazedoxifene (BZA) with conjugated estrogens (CE) has been evaluated in a series of phase 3 clinical trials. BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg have shown efficacy in reducing the frequency and severity of hot flushes, relieving VVA symptoms, and maintaining bone mass while protecting the endometrium and breast. These BZA/CE doses have been associated with a favorable safety/tolerability profile, with higher rates of cumulative amenorrhea and lower incidences of breast pain than those reported for EPT. Thus, BZA/CE may be a promising alternative to conventional EPT for treating non-hysterectomized, postmenopausal women.
Keywords: hormone therapy; tissue selective estrogen complex (TSEC); bazedoxifene; conjugated estrogens; menopause hormone therapy; tissue selective estrogen complex (TSEC); bazedoxifene; conjugated estrogens; menopause
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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MDPI and ACS Style

Komm, B.S.; Mirkin, S. The Tissue Selective Estrogen Complex: A Promising New Menopausal Therapy. Pharmaceuticals 2012, 5, 899-924.

AMA Style

Komm BS, Mirkin S. The Tissue Selective Estrogen Complex: A Promising New Menopausal Therapy. Pharmaceuticals. 2012; 5(9):899-924.

Chicago/Turabian Style

Komm, Barry S.; Mirkin, Sebastian. 2012. "The Tissue Selective Estrogen Complex: A Promising New Menopausal Therapy." Pharmaceuticals 5, no. 9: 899-924.


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