Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women

David F. Archer, Vivian Lewis, Bruce R. Carr, Sophie Olivier, James H. Pickar

Research output: Contribution to journalArticle

111 Citations (Scopus)

Abstract

Objective: To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. Design: International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting: Outpatient clinical. Patient(s): Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus. Intervention(s): Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo. Main Outcome Measure(s): Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years. Result(s): Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83% during cycles 1-13 and >93% during cycles 10-13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects. Conclusion(s): Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile.

Original languageEnglish (US)
Pages (from-to)1039-1044
Number of pages6
JournalFertility and Sterility
Volume92
Issue number3
DOIs
StatePublished - Sep 2009

Fingerprint

Conjugated (USP) Estrogens
Uterine Hemorrhage
Amenorrhea
Placebos
Incidence
Metrorrhagia
Hemorrhage
Estrogens
Therapeutics
Menopause
Uterus
Outpatients
Outcome Assessment (Health Care)
bazedoxifene

Keywords

  • amenorrhea
  • Bazedoxifene
  • BZA/CE
  • conjugated estrogens
  • postmenopausal
  • tissue selective estrogen complex
  • TSEC
  • uterine bleeding

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Reproductive Medicine

Cite this

Bazedoxifene/conjugated estrogens (BZA/CE) : incidence of uterine bleeding in postmenopausal women. / Archer, David F.; Lewis, Vivian; Carr, Bruce R.; Olivier, Sophie; Pickar, James H.

In: Fertility and Sterility, Vol. 92, No. 3, 09.2009, p. 1039-1044.

Research output: Contribution to journalArticle

Archer, David F. ; Lewis, Vivian ; Carr, Bruce R. ; Olivier, Sophie ; Pickar, James H. / Bazedoxifene/conjugated estrogens (BZA/CE) : incidence of uterine bleeding in postmenopausal women. In: Fertility and Sterility. 2009 ; Vol. 92, No. 3. pp. 1039-1044.
@article{a0d79e5d19a24a998acf73d1b12af232,
title = "Bazedoxifene/conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women",
abstract = "Objective: To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. Design: International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting: Outpatient clinical. Patient(s): Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus. Intervention(s): Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo. Main Outcome Measure(s): Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years. Result(s): Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83{\%} during cycles 1-13 and >93{\%} during cycles 10-13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects. Conclusion(s): Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile.",
keywords = "amenorrhea, Bazedoxifene, BZA/CE, conjugated estrogens, postmenopausal, tissue selective estrogen complex, TSEC, uterine bleeding",
author = "Archer, {David F.} and Vivian Lewis and Carr, {Bruce R.} and Sophie Olivier and Pickar, {James H.}",
year = "2009",
month = "9",
doi = "10.1016/j.fertnstert.2009.05.093",
language = "English (US)",
volume = "92",
pages = "1039--1044",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",
number = "3",

}

TY - JOUR

T1 - Bazedoxifene/conjugated estrogens (BZA/CE)

T2 - incidence of uterine bleeding in postmenopausal women

AU - Archer, David F.

AU - Lewis, Vivian

AU - Carr, Bruce R.

AU - Olivier, Sophie

AU - Pickar, James H.

PY - 2009/9

Y1 - 2009/9

N2 - Objective: To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. Design: International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting: Outpatient clinical. Patient(s): Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus. Intervention(s): Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo. Main Outcome Measure(s): Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years. Result(s): Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83% during cycles 1-13 and >93% during cycles 10-13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects. Conclusion(s): Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile.

AB - Objective: To evaluate the effect of bazedoxifene/conjugated estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. Design: International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting: Outpatient clinical. Patient(s): Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus. Intervention(s): Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo. Main Outcome Measure(s): Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years. Result(s): Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83% during cycles 1-13 and >93% during cycles 10-13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects. Conclusion(s): Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile.

KW - amenorrhea

KW - Bazedoxifene

KW - BZA/CE

KW - conjugated estrogens

KW - postmenopausal

KW - tissue selective estrogen complex

KW - TSEC

KW - uterine bleeding

UR - http://www.scopus.com/inward/record.url?scp=69049112720&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=69049112720&partnerID=8YFLogxK

U2 - 10.1016/j.fertnstert.2009.05.093

DO - 10.1016/j.fertnstert.2009.05.093

M3 - Article

C2 - 19635614

AN - SCOPUS:69049112720

VL - 92

SP - 1039

EP - 1044

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 3

ER -