Throughout history menopause has been shrouded in mystery, surrounded by strange superstitions and primitive treatments. As recently as the mid-1800s, menopausal women were prescribed opium, chloroform or even – alarmingly – vaginal injections with lead. It’s not surprising that doctors often used the term “hysterical” to describe their menopausal patients!1
Thankfully, our understanding of menopause has improved over time. With the arrival of menopausal hormone therapy (MHT) in the 1940s, women were finally able to access effective (and less gruesome) treatments for their symptoms.2 In fact, MHT is still the most effective treatment for vasomotor symptoms like hot flushes and night sweats.3
But the story doesn’t end there. The combination of progestin and estrogen in MHT had side effects like breakthrough bleeding and breast pain, often leading to women discontinuing their MHT and going back to battling their symptoms.4–6
Now a new era of MHT has begun with the discovery of TSECs (tissue-selective estrogen complexes). A TSEC is a novel approach to menopausal hormone therapy that combines a selective estrogen receptor modulator (SERM) with one or more estrogens.7
DUAVIVE is the first TSEC to be approved in Australia for treatment of vasomotor symptoms in postmenopausal women with a uterus.8 DUAVIVE combines conjugated estrogens with the SERM bazedoxifene to provide an effective, progestin-free alternative MHT.8
By acting selectively on different tissues, DUAVIVE relieves vasomotor symptoms like hot flushes, but has not shown unwanted effects in the uterus and breast.7 Importantly, 8 out of 10 DUAVIVE patients reported no breakthrough bleeding during the first year of treatment,*8,9,10 the number one reason women discontinue MHT.5
- Foxcroft, L. Hot flushes, cold science: a history of the modern menopause. Granata UK; 2010.
- Stefanick ML. Am J Med 2005;118(12B):64S–73S.
- The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Menopausal Hormone Therapy Advice. 2015. Available at: https://www.ranzcog.edu.au/RANZCOG_SITE/media/RANZCOG-MEDIA/Women’s%20Health/Statement%20and%20guidelines/Clinical%20-%20Gynaecology/Menopausal-Hormone-Therapy-Advice-(C-Gyn-16)-Re-write-July-2015.pdf?ext=.pdf (Accessed September 2018).
- Panay N, Studd Hum Reprod Update. 1997;3(2):159–71.
- Thiel C. Zentralbl Gynakol. 200;123(7):390–
- Australasian Menopause Society. Combined menopausal therapy (MHT) Available at: https://www.menopause.org.au/hp/information-sheets/267-combined-menopausal-hormone-therapy-mht (Accessed September 2018).
- Pinkerton JV et al. Climacteric 2013;16:618–28.
- DUAVIVE Product Information, 2016.
- Mirkin S et al. Climacteric. 2013;16:338–46.
- Pinkerton JV et al. J Clin Endocrinol Metab. 2014;99(2):E189–
PBS Information. This product is not listed on the PBS.
The risk associated with DUAVIVE is unknown due to the lack of long term safety data (see CONTRAINDICATIONS, PRECAUTIONS and ADVERSE EFFECTS, Description of Selected Adverse Reactions).
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women aged 50 to 79 years (mean age 63.6 years) during 7.1 years of treatment with conjugated estrogens (0.625 mg/day) alone therapy relative to placebo. Estrogen-alone therapy is also associated with an increase risk of ovarian cancer.
Before prescribing, please review Product Information available from Pfizer Australia Pty Ltd.
Minimum Product Information
DUAVIVE® 0.45/20 0.45 mg Conjugated Estrogens/20 mg Bazedoxifene Modified-release Tablets. Indications: Treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus. Use for the shortest duration consistent with treatment goals and risks for the individual woman. Experience in women older than 65 years is limited.
Contraindications: Hypersensitivity to conjugated estrogens, bazedoxifene or excipients; known, suspected or history of breast cancer, estrogen-dependent malignant tumours; undiagnosed genital bleeding; untreated endometrial hyperplasia; active or history of VTE, arterial thromboembolic disease; thrombophilic disorders; acute or history of liver disease, impaired liver function; porphyria; not for use in pregnant women, women who may become pregnant and nursing mothers.
Precautions: Pregnancy Category D. Co-administration with progestogens, additional estrogens or other SERMs is not recommended; full medical examination especially of breast health before initiation and reinstituting treatment; close supervision for: leiomyoma or endometriosis, thromboembolic disorders, estrogen-dependent tumours risk factors, hypertension, liver disorders, diabetes mellitus, cholelithiasis, coronary artery disease and stroke, migraine, systemic lupus erythematosus, endometrial hyperplasia history, epilepsy, asthma, otosclerosis; discontinue with first signs or if suspected VTE, stroke, pregnancy, jaundice or deteriorating liver function, significant increase in blood pressure, new onset of migraine-type headache; may increase risk of endometrial hyperplasia and carcinoma, ovarian cancer, breast cancer; risk of VTE; cholecystitis; pre-existing hypertriglyceridaemia; fluid retention; renal impairment; increase thyroid binding globulin; driving or operating machines. See PI for details.
Interactions with other Medicines: Inducers of drug-metabolism enzymens, e.g., anticonvulsants, anti-infectives, St John’s wort (Hypericum perforatum); CYP3A4 inhibitors; Uridine diphosphate glucuronosyltransferase inducers. See PI for details.
Adverse Effects: Very common and common: Abdominal pain; vulvovaginal candidiasis; constipation; diarrhoea; nausea; muscle spasms; blood trigylcerides increased, breast pain/tenderness. Rare: VTE. Post-market: Ocular events other than retinal thrombosis. See PI for details. Dosage and Administration: CE 0.45 mg/bazedoxifene 20 mg taken once daily with or without food. Tablets swallowed whole; not chewed, crushed or broken. See PI for details. V11216
Pfizer Australia Pty Limited. Sydney, Australia. Medical Information: 1800 675 229. Date of Preparation: October 2018. PP-DUA-AUS-0322. PFWH14729W. Ward6.