Duavee (conjugated estrogens / bazedoxifene) / Pfizer, Ligand - LARVOL DELTA

The PROMISE Study: Duavee in Women With DCIS (clinicaltrials.gov) - P2 | N=142 | Completed | Sponsor: Northwestern University | Recruiting ➔ Completed | Trial primary completion date: Aug 2023 ➔ Jun 2024

Trial completion • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • AGR2 • PTGS2 • UGT1A1

Bazedoxifene as a Potential Cancer Therapeutic Agent Targeting IL-6/GP130 Signaling. (PubMed, Curr Oncol) - "Numerous studies have highlighted the efficacy of BZA (monotherapy or combined with other chemotherapy drugs) in impeding progression across multiple cancers. In this review, we mainly focus on the anticancer activity of BZA and the underlying anticancer mechanism through inhibition of the IL-6/GP130 pathway, aiming to provide valuable insights for the design and execution of further research and the potential repositioning of BZA in oncological clinical trials."

Journal • Review • Oncology • Osteoporosis • Rheumatology • IL6

Overcoming challenges in conducting early phase breast cancer prevention trials: Bazedoxifene and conjugated estrogens vs waitlist control. (PubMed, Contemp Clin Trials) - P2 | "Despite a late start, accrual is likely to be completed within the funding period. NCT04821141."

Journal • Breast Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Osteoporosis • Rheumatology • Solid Tumor

Drugs for postmenopausal osteoporosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Review • Osteoporosis • Rheumatology

Comparison table: Some drugs for postmenopausal osteoporosis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Osteoporosis • Rheumatology

Navigating the Challenges of Menopause: Effective Symptom Management - PT2 (ACOG 2024) - "Select the Product Theater you would like to attend. Click continue, then "Checkout" to save it to your registration."

Women's Health

CE/BZA: Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: VA Office of Research and Development | N=40 ➔ 0 | Trial completion date: May 2026 ➔ Apr 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Sep 2025 ➔ Apr 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Genetic Disorders • Metabolic Disorders • Obesity

The Effects of Tissue Selective Estrogen Complex (TSEC) Duavee on Mood Symptoms and Resting State Functional Connectivity in Perimenopausal Depression (SOBP 2024) - "Safety considerations and side effects contribute to limitations of traditional estrogen treatment for PO-MDD. suggest that Duavee reduces mood symptoms and targets neural connectivity without the concurrent risk profile. Further research is needed to understand potential links between these effects."

CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Drugs for menopausal symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

CE/BZA: Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Dec 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Metabolic Disorders • Obesity

CE/BZA: Effects of Novel Estrogens on Glucose and Lipids in Postmenopausal Prediabetic Women Veterans (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Metabolic Disorders • Obesity

Endo2/SA3: Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee (clinicaltrials.gov) - P4 | N=28 | Recruiting | Sponsor: Penn State University | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Cardiovascular • Endometriosis • Gynecology • Women's Health

Endo2/SA3: Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee (clinicaltrials.gov) - P4 | N=28 | Recruiting | Sponsor: Penn State University | Trial primary completion date: Dec 2025 ➔ Jun 2025

Trial primary completion date • Cardiovascular • Endometriosis • Gynecology • Women's Health

Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM) (clinicaltrials.gov) - P4 | N=17 | Completed | Sponsor: Tulane University Health Sciences Center | N=12 ➔ 17

Enrollment change • Genetic Disorders • Obesity • CRP • FGF21 • LCN2 • LEP

Fezolinetant (Veozah) for menopausal vasomotor symptoms. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal

[VIRTUAL] Effect of Omalizumab for Autoimmune Progesterone Dermatitis Refractory to Bilateral Oophorectomy: A Case Report (ENDO 2021) - "Her symptoms were improved with oral prednisone use, however breakthrough episodes still occurred...Vasomotor menopausal symptoms were resolved using conjugated estrogens with bazedoxifene...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Clinical • Cardiovascular • Dermatitis • Dermatology • Endocrine Disorders • Gynecology • Immunology • Musculoskeletal Pain • Pain

Preventing estrogen receptor alpha-positive breast cancer outgrowth with the use of hormone replacement therapy (AACR 2018) - "...Follow-up sudies suggest that breast cancer cases from PremPro treatment were primarily due to the outgrowth of occult tumors, not the formation of new disease. Duavee, a more recent form of HRT that combines CE and bazedoxifene (BZA), a selective estrogen receptor modulator (SERM) and degrader (SERD), has been approved by the FDA for treatment of moderate to severe hot flashes and to reduce the risk of osteoporosis...In addition, CE+BZA was able to decrease the rate of tumor growth in an ER-positive patient-derived xenograft (PDX) mouse model. An improved understanding of the molecular mechanisms of CE+BZA action in hormone sensitive breast cancer cell and animal models should have important implications for women considering HRT."

Hormone Receptor Breast Cancer

Pilot study of the combination of bazedoxifene and conjugated estrogen to modulate risk biomarkers in women with hot flashes at increased risk for breast cancer (AACR 2018) - "...For the first ten subjects where serum hormones and growth factors were assessed in paired assays, favorable modulation was observed for estradiol, testosterone, SHBG, bioavailable testosterone, IGF-1, and the molar ratio of IGF1:IGFBP3...Duavee provided by Pfizer, Inc. which was not involved in design, conduct, or analysis of the study."

Biomarker • BRCA Biomarker • Clinical • IO Biomarker • Breast Cancer

[VIRTUAL] The challenge of SERMs (ISGE-I 2020) - "The SERMs assessed appear to have antiestrogenic or neutral effects on the breast; Tamoxifen, Raloxifene, and Lasofoxifene have shown antiestrogenic effects in clinical trials; and Bazedoxifene and Ospemifene have shown antiestrogenic effects in preclinical trials but appear to be neutral in clinical trials to date...Another interesting concept would be TSEC, a combination of Bazedoxifene with conjugated Estrogens...There is no breast or endometrial stimulation with treatment, and cardiovascular risk is not increased, and may be an alternative to HT. The rapid developments in molecular biology incorporates enormous possibilities on molecular biology, stem cells, cell biology in concurrence with genomics, functional genomics, genetics, proteomics, makes us optimistic, about the future of different estrogen modulators in not too long term in term."

Cardiovascular • Vaginal Atrophy • Venous Thromboembolism

DOMA: Affect of Duavive on Mood & Anxiety Symptoms (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: St. Joseph's Healthcare Hamilton; Initiation date: Sep 2020 ➔ Mar 2021

Clinical • Trial initiation date • CNS Disorders • Depression • Mood Disorders • Psychiatry

Effect of conjugated estrogens and bazedoxifene on glucose, energy and lipid metabolism in obese postmenopausal women. (PubMed, Eur J Endocrinol) - "A short treatment of obese postmenopausal women with CE/BZA does not alter insulin action or ectopic fat but increases serum markers of hepatic de novo lipogenesis and TAG production."

Clinical • Journal • Dyslipidemia • Genetic Disorders • Obesity

Carboplatin-pemetrexed in treatment of patients with recurrent/metastatic cancers of the head and neck; superior outcomes in oropharyngeal primaries. (PubMed) - "Combination carboplatin-pemetrexed is an effective and well-tolerated treatment, associated with a median PFS of 5.1?months and a clinical benefit in at least 57% of the patients treated."

Journal • Biosimilar • Esophageal Cancer • Head and Neck Cancer • Oncology

DOMA: Affect of Duavive on Mood & Anxiety Symptoms (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: St. Joseph's Healthcare Hamilton

Clinical • New P1 trial • CNS Disorders • Depression • Mood Disorders

Adverse events and infections in patients with rheumatoid arthritis treated with conventional drugs or biologic agents: a real world study. (PubMed) - "The risk of any AE among RA patients treated with bDMARDs was significantly higher compared to those treated with sDMARDs."

Journal • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Successful treatment of subacute constrictive pericarditis with interleukin-1? receptor antagonist (anakinra). (PubMed) - No abstract available

Journal • Biosimilar • Immunology • Inflammation