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Beyond estrogen: advances in tissue selective estrogen complexes and selective estrogen receptor modulators

J V Pinkerton1, E A Conner1

  • 1a Department of Obstetrics and Gynecology, Division of Midlife Health , University of Virginia Health System , Charlottesville , VA , USA.

Climacteric : the Journal of the International Menopause Society
|March 22, 2019
PubMed

Insights

Selective estrogen receptor modulators (SERMs) offer targeted benefits for women's health. Conjugated equine estrogens/bazedoxifene effectively treats menopause symptoms and prevents bone loss without increasing breast cancer risk.

Area of Science:

  • Endocrinology
  • Pharmacology
  • Women's Health

Background:

  • Selective estrogen receptor modulators (SERMs) are non-steroidal agents with tissue-specific estrogenic and anti-estrogenic effects.
  • Existing SERMs like tamoxifen and raloxifene have demonstrated efficacy in breast cancer, osteoporosis, and menopausal symptom management.
  • The development of novel SERMs and estrogen-based therapies aims to optimize therapeutic outcomes while minimizing adverse effects.

Purpose of the Study:

  • To evaluate the efficacy and safety of a tissue-selective estrogen complex (CEE/BZA) in postmenopausal women.
  • To assess the impact of CEE/BZA on vasomotor symptoms, vulvovaginal atrophy, bone mineral density, and breast health.
  • To investigate the endometrial effects and safety profile of CEE/BZA compared to placebo.

Main Methods:

  • The study analyzed data from the Selective Estrogen Menopause and Response to Therapy (SMART) trials.
  • Participants received conjugated equine estrogens (CEE) 0.45 mg combined with bazedoxifene (BZA) 20 mg.
  • Outcomes were assessed over up to two years, including symptom improvement, bone density, and breast/endometrial safety.

Main Results:

  • CEE/BZA significantly improved moderate to severe vasomotor symptoms and vulvovaginal atrophy.
  • The treatment effectively prevented bone loss at the lumbar spine and total hip.
  • CEE/BZA demonstrated neutrality regarding breast tenderness and density, with breast cancer incidence similar to placebo. Endometrial safety was confirmed, with hyperplasia and cancer rates comparable to placebo.

Conclusions:

  • The combination of conjugated equine estrogens and bazedoxifene (CEE/BZA) is an effective treatment for menopausal vasomotor symptoms and prevention of bone loss.
  • CEE/BZA offers a favorable safety profile, showing no adverse effects on the breast and providing endometrial protection.
  • This therapy represents a valuable option for managing menopausal symptoms and associated bone loss in postmenopausal women.
Keywords:
Selective estrogen receptor modulatorsbazedoxifenebazedoxifene/conjugated estrogensconjugated estrogensestetrolraloxifenetamoxifentissue selective estrogen complex

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