This study evaluates the impact of conjugated estrogens/ bazedoxifene (CE/ BZA) on the mood (depression and anxiety) in peri- and early menopausal women.

Start Date03 Jul 2024

Sponsor / Collaborator

St. Joseph's Healthcare Hamilton

[+2]

NCT05059626

/ RecruitingPhase 4IIT

Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis

Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis.
Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.

Start Date01 Dec 2023

Sponsor / Collaborator

The Pennsylvania State University

[+1]

NCT04821375

/ Active, not recruitingEarly Phase 1IIT

Pilot Study of Effects of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers In Women With Menopausal Symptoms at Increased Risk for Breast Cancer

Pilot study to test feasibility of 6 months of bazedoxifene (BZA) plus conjugated estrogens (CE) to modulate breast MRI parameters.

Start Date02 Dec 2021

Sponsor / Collaborator

University of Kansas

100 Clinical Results associated with Conjugated Estrogens/Bazedoxifene Acetate

100 Translational Medicine associated with Conjugated Estrogens/Bazedoxifene Acetate

100 Patents (Medical) associated with Conjugated Estrogens/Bazedoxifene Acetate

Literatures (Medical) associated with Conjugated Estrogens/Bazedoxifene Acetate

01 Nov 2024·Contemporary Clinical Trials

Overcoming challenges in conducting early phase breast cancer prevention trials: Bazedoxifene and conjugated estrogens vs waitlist control

Article

Author: Kimler, Bruce F. ; Altman, Christy ; Garber, Judy E ; Fabian, Carol J. ; Mudaranthakam, Dinesh Pal ; Esserman, Laura J ; Khan, Seema A. ; Winblad, Onalisa ; Esserman, Laura J. ; Ranallo, Lori ; Pittman, Krystal ; Metheny, Trina ; Yee, Lisa D ; Powers, Kandy R ; Komm, Barry S. ; Komm, Barry S ; Zelenchuk, Adrian ; Kimler, Bruce F ; Gajewski, Byron ; Powers, Kandy R. ; Yee, Lisa D. ; Kreutzjans, Amy L. ; Nye, Lauren ; Garber, Judy E. ; Kreutzjans, Amy L ; Fabian, Carol J ; Young, Kate ; Khan, Seema A

BACKGROUND:

The combination of bazedoxifene 20 mg (BZA) and conjugated estrogens 0.45 mg (CE) marketed as Duavee® is approved for vasomotor symptom relief and osteoporosis prevention. Our pilot study suggested it had potential breast cancer risk reduction, and we proposed a multisite Phase IIB primary prevention trial assessing change in breast imaging and tissue risk biomarkers. By the time funding was acquired in February 2021, Duavee® was unavailable with an uncertain return date. A redesign was needed to salvage the study.

METHODS:

The basic trial design was minimally altered. Women age 45-64 at elevated risk for breast cancer with vasomotor symptoms and no menses for at least 2 months have mammography, phlebotomy, and benign breast tissue sampling before and after 6 months of intervention. However, instead of Duavee® (single pill) vs placebo, women are randomized to 6 months of BZA + CE vs Waitlist. Those initially randomized to Waitlist can receive BZA + CE after 6 months. The primary endpoint is between arm difference in change in a fully automated measure of mammographic density with blood and tissue-based secondary endpoints.

OUTCOMES:

Accrual initiation was delayed due to contractual difficulties surrounding BZA importation during COVID-19 and deploying a fully automated method (Volpara®) to assess the primary endpoint. To accommodate this delay, a mid-grant no cost extension along with amended eligibility requirements were employed. 61/120 participants needed were entered in the initial 27 months of accrual and 37 months of funding. Despite a late start, accrual is likely to be completed within the funding period.

01 May 2022·Multiple sclerosis and related disorders

A hormonal therapy for menopausal women with MS: A phase Ib/IIa randomized controlled trial

Article

Author: Joffe, Hadine ; Krysko, Kristen M ; Zamvil, Scott S ; Chan, Jonah R ; Gelfand, Jeffrey M ; Henry, Roland G ; Anderson, Annika ; Green, Ari J ; Bove, Riley ; Rush, Gillian ; Cree, Bruce A C ; Hills, Nancy K ; Rankin, Kelsey A ; Graves, Jennifer S ; Rowles, William ; Carleton, Mia ; Cooper, Joanna

INTRODUCTION:

Most women develop MS before menopause. Menopausal hot flashes can worsen MS symptoms, and could be relieved with hormone therapy. Our objective was to evaluate feasibility, tolerability and symptom response of Duavee® (bazedoxifene + conjugated estrogen) in a Phase Ib/IIa double-blind randomized controlled clinical trial.

METHODS:

We randomized 24 peri/postmenopausal women with MS and symptomatic hot flashes 1:1 to Duavee® versus placebo. Evaluations occurred at baseline and 2 months.

RESULTS:

Groups were balanced for age (mean 51.2 ± 3.6 years), EDSS [median 3 (IQR:2.5, 4.5)], and MS duration. 21/24 participants completed the study.

FEASIBILITY:

Enrollment was protracted (34 months), partially due to concerns about hormone therapy safety.

TOLERABILITY:

treatment group participants reported greater satisfaction and fewer missed doses; one participant (placebo) developed new MRI lesions; liver function testing remained normal for all patients.

SYMPTOMS:

Hot Flash Related Daily Interference scale at 2 months was lower in treatment vs. placebo group [median (IQR) of 4 (0.5, 14) vs. 9 (0, 33)]. Between-group differences were not statistically significant.

CONCLUSION:

Despite perceived benefits in MS, estrogens have perceived risks that represent a hurdle to enrollment. With appropriate education and screening of participants, the favorable study retention (87%) and treatment satisfaction observed in the current study support the feasibility of a longer, powered trial to evaluate whether a proven treatment for menopausal symptoms, Duavee®, could also improve MS-related function in menopausal women with MS.

01 Dec 2021·Pilot and feasibility studies

Hand Osteoarthritis: investigating Pain Effects of estrogen-containing therapy (HOPE-e): a protocol for a feasibility randomised placebo-controlled trial

Article

Author: Gulati, Malvika ; Williams, Jennifer A E ; Gardiner, Matthew ; Goff, Megan ; Vincent, Katy ; Dutton, Susan J ; Glover, Victoria ; Francis, Anne ; Woollacott, Sue ; Marian, Ioana R ; Black, Joanna ; Barber, Vicki S ; Chester-Jones, Mae ; Furniss, Dominic ; Watson, Marion ; Mackworth-Young, Charles ; Watt, Fiona E ; Lamb, Sarah E ; Vincent, Tonia L

Abstract:

Background:

Hand osteoarthritis (OA) is a common condition, causing pain, stiffness and reduced quality of life. Incidence is higher amongst women, particularly around the age of the menopause. Whilst the relationship between sex hormones and OA has been studied in vitro, in epidemiological studies and in clinical trials of hormone replacement therapy (HRT), this study is the first to investigate the effect of estrogen-containing therapy on hand pain in post-menopausal women with symptomatic hand OA in a randomised study design.

Methods:

This is a feasibility study of a double-blinded placebo-controlled intervention with 1:1 randomisation to either a combination of conjugated estrogens 0.45 mg and bazedoxifene acetate 20 mg (Duavive) or placebo. The target population is post-menopausal women with symptomatic hand OA, aiming to recruit 60–90 study participants. The primary objective is to assess the feasibility of a future fully powered randomised controlled trial (RCT). Participants will take the study medication for 24 weeks and be followed up for 28 weeks after randomisation. The primary outcomes used to determine feasibility are eligible participant identification rates and routes; recruitment, randomisation and retention rates of eligible participants; study medication compliance; and the likelihood of unintentional unblinding. Secondary outcomes include measures of hand pain, function, appearance and menopausal symptoms. An end of study questionnaire and focus groups will help to refine the final protocol for a full study.

Discussion:

Identifying new treatments for symptomatic hand OA is a recognised research priority. The study will help us to understand whether there are sufficient interested and eligible individuals in this target population who would consider HRT for their hand symptoms. It will provide proof-of-concept RCT data on the effects of HRT on hand pain and other clinically relevant outcomes in this population. The study will gain valuable information on the feasibility of a full RCT and how best to run this. The findings will be published in a peer-reviewed journal and presented at a relevant conference.

Trial registration:

ISRCTN12196200 registered on 15 January 2019.

News (Medical) associated with Conjugated Estrogens/Bazedoxifene Acetate

12 Sep 2023

·www.prnewswire.com

Menopause Market to Grow Rapidly at a CAGR of 1.2% by 2032, Predicts DelveInsight

The menopause market is anticipated to surge significantly in the coming years due to the emergence of new products in the pipeline. In addition, persistently rising cases of menopause in the forecast period will help increase the menopause treatment market. LAS VEGAS, Sept. 12, 2023 /PRNewswire/ -- DelveInsight's Menopause Market Insights report includes a comprehensive understanding of current treatment practices, menopause emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Menopause Market Report As per DelveInsight analysis, the menopause market size in the 7MM was approximately USD 11 billion in 2022. According to the assessment done by DelveInsight, the total number of women in menopause in the 7MM comprised approximately 100 million cases in 2022 and are projected to increase during the forecast period. Leading menopause companies such as Viramal Limited, Simbec Research, Estetra, Mithra Pharmaceuticals, Bayer, Nerre Therapeutics Ltd., Mitsubishi Tanabe Pharma America Inc., MenoGeniX, QUE Oncology, Fervent Pharmaceuticals, and others are developing novel menopause drugs that can be available in the menopause market in the coming years. The promising menopause therapies in the pipeline include Transdermal Estradiol Cream (VML-0203), DONESTA (E4, Estetrol), Elinzanetant (BAY3427080), MT-8554 (Elismetrep), MNGX-100 (Filgrastim/G-CSF), Q-122 (MSX-122), FP-101, and others. Discover which therapies are expected to grab the major menopause market share @ Menopause Market Report Menopause Overview Menopause is a natural biological process that marks the end of a woman's reproductive years. It usually occurs between the ages of 45 and 55, with an average age of around 51. This phase is characterized by a decline in the production of hormones like estrogen and progesterone, leading to the cessation of menstruation and fertility. The primary cause of menopause is the aging of the ovaries, which results in a reduced number of eggs and a decline in hormone production. However, certain medical procedures like hysterectomy, chemotherapy, and radiation therapy can induce menopause prematurely. Menopause brings about a range of symptoms that can vary widely from woman to woman. Common menopause symptoms include hot flashes, night sweats, mood swings, irritability, fatigue, vaginal dryness, and sleep disturbances. These symptoms occur due to the hormonal fluctuations that take place during the transition to menopause. Diagnosing menopause is often based on a woman's age, medical history, and symptoms. A key factor is the absence of menstruation for 12 consecutive months, signaling the end of the reproductive period. In some cases, healthcare providers may recommend blood tests to measure hormone levels, such as follicle-stimulating hormone (FSH) and estrogen, to confirm the onset of menopause. Menopause Epidemiology Segmentation DelveInsight estimates that there were approximately 100 million total women in menopause in the 7MM in 2022. For the age-specific analysis, the number of cases of menopause were distributed across various age groups, such as <40 years, 40–50 years, 51–60 years, and 61–65 years, in the 7MM. As per the analysis, the highest number of cases were estimated in the age-group 51-60 years and the lowest in <40 years with 64 million and 3.4 million cases, respectively in 2022. The menopause market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Number of Women in Menopause Stage-Specific Distribution of Women in Menopause Age-Specific Distribution of Women in Menopause Number of Women in Menopause with Vasomotor Symptoms Number of Women in Menopause with Moderate-to-Severe Vasomotor Symptoms Menopause Treatment Market The North American Menopause Society (NAMS) suggests waiting until the hot flashes become troublesome to the woman before seeking treatment. The intensity of symptoms, an assessment of treatment-related risks, and the woman's views towards menopause and drugs should all be considered before starting treatment. Duavee (bazedoxifene acetate/conjugated estrogens) is the first and only medicine that combines CE with an estrogen agonist/antagonist, commonly known as a selective estrogen receptor modulator (SERM), for the treatment of menopausal VMS. Duavee employs bazedoxifene rather than progestin to help protect the uterine lining from hyperplasia that may occur as a result of estrogen-only treatment. Many women use non-prescription therapies to address disorders such as hot flashes, such as isoflavones, black cohosh, and progesterone-containing hormone lotions. The clinical evidence for the efficacy and long-term safety of these therapies is insufficient. Furthermore, most over-the-counter medications for hot flashes are classified as nutritional supplements and, as such, are not regulated by the US Food and Drug Administration. Prescription medications for various purposes that have demonstrated some benefit in alleviating hot flashes are available for women who have hot flashes but cannot undergo hormone therapy. Certain prescription antidepressants may reduce hot flashes in women, including those with a history of breast cancer. Others include gabapentin, clonidine, and methyldopa. The NAMS recommends that women who need relief from mild menopause-related hot flashes first consider lifestyle changes such as manipulating the environment to keep the core body temperature cool, getting regular exercise, quitting smoking, and using relaxation techniques such as paced respiration. To know more about menopause treatment, visit @ Menopause Treatment Drugs Key Menopause Therapies and Companies Transdermal Estradiol Cream (VML-0203): Viramal Limited/Simbec Research DONESTA (E4, Estetrol): Estetra/Mithra Pharmaceuticals Elinzanetant (BAY3427080): Bayer|Nerre Therapeutics Ltd. MT-8554 (Elismetrep): Mitsubishi Tanabe Pharma America Inc. MNGX-100 (Filgrastim/G-CSF): MenoGeniX Q-122 (MSX-122): QUE Oncology FP-101: Fervent Pharmaceuticals Learn more about the FDA-approved drugs for menopause @ Drugs for Menopause Treatment Menopause Market Dynamics The menopause market dynamics are undergoing significant shifts as societal awareness of women's health and well-being continues to grow. With an aging population and increasing focus on women's empowerment, there's a heightened demand for innovative products and services addressing the physical and emotional challenges associated with menopause. This has spurred a surge in research and development, leading to the creation of a diverse range of hormone replacement therapies, herbal supplements, lifestyle apps, and personalized health plans. As more women seek effective and holistic solutions, companies are embracing a more consumer-centric approach, tailoring their offerings to individual needs and preferences. Additionally, discussions around menopause are becoming less taboo, allowing for open dialogue and information-sharing, further shaping the menopause market dynamics by fostering a supportive ecosystem for women navigating this life stage. However, despite the potential for growth, this menopause market is not without its barriers. Stringent regulatory processes for hormonal treatments and supplements, coupled with concerns about product safety and efficacy, pose challenges for menopause market entrants. Additionally, cultural stigmas and misinformation surrounding menopause still exist in certain societies, inhibiting open discussions and the adoption of new solutions. Economic disparities and limited access to healthcare further compound these issues, preventing equal menopause market penetration. Overcoming these barriers requires a multi-faceted approach, involving education, regulatory reforms, and inclusive product development, to truly tap into the menopause market's potential. Scope of the Menopause Market Report Therapeutic Assessment: Menopause current marketed and emerging therapies Menopause Market Dynamics: Attribute Analysis of Emerging Menopause Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Menopause Market Access and Reimbursement Discover more about menopause drugs in development @ Menopause Clinical Trials Table of Contents Related Reports Hot Flashes Pipeline Hot Flashes Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, Pherin Pharmaceuticals, among others. Hot Flashes Market Hot Flashes Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key hot flashes companies, including Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, among others. Menopause Global Market Menopause Market Insights, Competitive Landscape, and Market Forecast – 2028 report deliver an in-depth understanding of the disease, market trends, market drivers, market barriers, and key menopause companies including ISIDEN, Novapharm, Arkopharma, Pileje, Thermamex, ÉLERTÉ Laboratories, Serelys Pharma, Besins Healthcare, Bayer, ITALFARMACO S.p.A, Pfizer Inc, Mylan NV, Teva Pharmaceuticals, TherapeuticsMD, Inc, Novo Nordisk, Novartis, Millicent Pharma, PADAGIS LLC, Vertical Pharmaceuticals LLC, Amgen, among others. Vasomotor Symptoms of Menopause Pipeline Vasomotor Symptoms of Menopause Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key vasomotor symptoms of menopause companies, including Mithra Pharmaceuticals, Acer Therapeutics, QUE Oncology, Bayer, Endoceutics, Astellas Pharma, Mitsubishi Tanabe Pharma, MenoGenix, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

100 Deals associated with Conjugated Estrogens/Bazedoxifene Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G03CC07	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Oestrogen deficiency	EU	Pfizer Europe MA EEIG	16 Dec 2014
Oestrogen deficiency	IS	Pfizer Europe MA EEIG	16 Dec 2014
Oestrogen deficiency	LI	Pfizer Europe MA EEIG	16 Dec 2014
Oestrogen deficiency	NO	Pfizer Europe MA EEIG	16 Dec 2014
Osteoporosis, Postmenopausal	US	Wyeth Pharmaceuticals LLC	03 Oct 2013
Vasomotor symptom	US	Wyeth Pharmaceuticals LLC	03 Oct 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Vulvovaginal atrophy	Phase 3	US	Wyeth AB	01 Oct 2005
Endometrial Hyperplasia	Phase 3	-	Wyeth AB	01 Apr 2002
Osteoporosis	Phase 3	-	Wyeth AB	01 Apr 2002
Ductal Carcinoma	Phase 2	US	Pfizer Inc.	01 Jan 2017
Noninfiltrating Intraductal Carcinoma	Phase 2	US	Pfizer Inc.	01 Jan 2017
Breast Cancer	Phase 2	US	Pfizer Inc.	01 May 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03740009 (Duavee, CTgov)	Phase 4	Depressive Disorder	20	Bazedoxifene/Conjugated Estrogen	typyfcinrw(bhotfiapzs) = zrkmdiapeb kqemntlqeo (opseabpmxw, fvhvzwbfab - qoltqfudin) View more	-	10 May 2022
NCT02729701 (CTgov)	Phase 2	Breast Cancer	28	Duavee	xcmlmxklbo(amncoxbpdm) = gfcrpoigwu iiiazsnrbx (mqejfiivxc, rnrukwlmbh - koijrcmfkw) View more	-	09 Mar 2022
NCT00242710 (CTgov)	Phase 3	Endometrial Hyperplasia \| Osteoporosis	1,083	Bazedoxifene (Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg)	jlzrswufck(otgrwcupcs) = rcjyghouug nvwnslnoxn (pbomkpgfoj, ieljcodrvh - mhyjkmxguu) View more	-	20 Dec 2013
				Bazedoxifene (Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg)	jlzrswufck(otgrwcupcs) = kavsrocjys nvwnslnoxn (pbomkpgfoj, pvafztmfzg - isvyayjuql) View more
NCT00808132 (Selective estrogens, Menopause, And Response to Therapy-5, Pubmed \| Obstet Gynecol)	Phase 3	-	1,886	Bazedoxifene 20 mg and conjugated estrogens 0.45 mg	nuqobmaaqi(phzyhkbkgd) = Both bazedoxifene-conjugated estrogens doses showed rates of breast tenderness similar to placebo and significantly (P<.001) lower than conjugated estrogens-medroxyprogesterone acetate vkotmxitpe (taoduvijva ) View more	Positive	01 May 2013
				Bazedoxifene 20 mg and conjugated estrogens 0.625 mg

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