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Updated: May 5, 2026

An In Vivo Estrogen Deficiency Mouse Model for Screening Exogenous Estrogen Treatments of Cardiovascular Dysfunction After Menopause
Published on: August 13, 2019
The tissue selective estrogen complex: a promising new menopausal therapy.
Barry S Komm1, Sebastian Mirkin
1Women's Health, Pfizer Inc., 500 Arcola Rd., Collegeville, PA 19426, USA. Barry.Komm@pfizer.com.
Tissue selective estrogen complex (TSEC) offers a new option for menopausal symptom relief. Bazedoxifene (BZA) combined with conjugated estrogens (CE) effectively treats hot flashes and vaginal atrophy while protecting bone and reproductive health.
Area of Science:
- Reproductive Endocrinology
- Pharmacology
- Women's Health
Background:
- Menopause presents health challenges like vasomotor symptoms, vulvar/vaginal atrophy (VVA), and osteoporosis.
- Estrogen therapy (ET) and estrogen-progestin therapy (EPT) are standard treatments but carry safety concerns.
- Alternative therapies are needed to manage menopausal symptoms and prevent bone loss.
Purpose of the Study:
- To evaluate the efficacy and safety of tissue selective estrogen complex (TSEC) agents for menopausal symptom management.
- To assess the effectiveness of bazedoxifene (BZA) combined with conjugated estrogens (CE) in treating non-hysterectomized, postmenopausal women.
- To compare the safety and tolerability profile of BZA/CE with conventional EPT.
Main Methods:
- Phase 3 clinical trials were conducted to assess BZA/CE efficacy and safety.
- Dosages evaluated included BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg.
- Outcomes measured included reduction in hot flashes, VVA symptom relief, bone mass maintenance, and endometrial/breast safety.
Main Results:
- BZA/CE demonstrated efficacy in reducing hot flush frequency and severity.
- Significant relief from vulvar/vaginal atrophy symptoms was observed.
- Bone mass was maintained, and the endometrium and breast were protected.
- Higher rates of amenorrhea and lower incidences of breast pain were noted compared to EPT.
Conclusions:
- BZA/CE is an effective treatment for menopausal symptoms, including hot flashes and VVA.
- This TSEC formulation shows a favorable safety and tolerability profile.
- BZA/CE represents a promising alternative to traditional EPT for eligible postmenopausal women.

