PAD Refills

What is the role of Duavive in the management of menopause symptoms?

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The BC Provincial Academic Detailing (PAD) Medications for menopause-associated vasomotor and genitourinary symptoms delivers evidence and practical drug information for the most commonly prescribed estrogen and progestogen products (oral, transdermal, vaginal).¹ Visit www.bcpad.ca to book a session with an academic detailing pharmacist in your area. We received this question during PAD sessions: What is Duavive and what is its role?

Basics²

Conjugated estrogens/bazedoxifene (CE/BZA), tradename Duavive, combines 0.45 mg of conjugated estrogens and 20 mg of bazedoxifene in each oral tablet. In Canada, CE/BZA is approved for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause in women with a uterus. Bazedoxifene is a selective estrogen receptor modulator (SERM) that provides endometrial protection, so a concurrent progestogen is not required. CE/BZA is often referred to as a tissue selective estrogen complex (TSEC).

Cost and BC PharmaCare coverage^3,4

The current annual cost of CE/BZA is approximately $1,200 (excluding markup and professional fees). CE/BZA is not a BC PharmaCare benefit.

Evidence for vasomotor symptoms^2,5,6

The principal efficacy trial for CE/BZA, a 12-week study, enrolled 318 healthy, post-menopausal women with a mean age of 53. At baseline, participants were experiencing ~10 moderate to severe hot flashes per day. By week 12, CE/BZA effectively reduced the number of hot flashes to ~2 per day. Its efficacy is comparable to that of other estrogen products. CE/BZA has not been studied in perimenopausal women experiencing hot flashes.

Canadian menopause guidelines on the role of Duavive^2,7,8

The Society of Obstetricians and Gynecologists (SOGC) 2021 guideline identifies CE/BZA as an option for patients with a uterus who do not tolerate the progestogen component of menopause hormone therapy. The SOGC further highlighted a phase 3 clinical trial that demonstrated no significant changes in mammographic breast density after 24 months of continuous use of CE/BZA.⁸ While there is interest in the role for CE/BZA in women with additional risk factors for breast cancer, such as those with dense breasts, no formal recommendations are made in this context.

To date there are no phase 3 clinical trials examining the effect of CE/BZA on breast cancer outcomes and there are no phase 3 clinical trials comparing CE/BZA to estrogen plus a progestogen. Like all estrogen/progestogen containing products, CE/BZA is not recommended for use in people with a past or current history of hormone dependent cancers.² For a more detailed discussion of oncology considerations, please refer to BC PAD’s Handout Medications for menopause-associated vasomotor and genitourinary symptoms (PDF, 538KB).

Some practical considerations:²

• CE/BZA is only available in one fixed-dose combination; thus, there is no flexibility for titration or tapering
• CE/BZA is supplied as a modified-release oral tablet; it cannot be cut, chewed, or crushed
• Health Canada does not currently differentiate CE/BZA from other estrogen-containing products in terms of its contraindications and risks

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¹BC PAD Service Medications for Menopause-Associated Vasomotor and Genitourinary Symptoms (May 2025); ²Health Canada Drug Product Database; ³McKesson Canada (accessed October 6, 2025); ⁴BC PharmaCare Formulary Search; ⁵Pinkerton Menopause 2009 (PMID:19546826); ⁶US Food & Drug Administration Approved Drugs 2013 Medical Review Duavee; ⁷Yuksel J Obstet Gynecol Can 2021 (PMID:34390867); ⁸Harvey Menopause 2013 (PMID:23271189).