CLINICAL TRIALS PROFILE FOR DUAVEE

All Clinical Trials for DUAVEE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02100553 ↗	Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women	Completed	Pfizer	Phase 1	2014-04-01	This study will assess if itraconazole will affect the blood levels of Duavee when they are given together. This study will also assess if a subject's body size affects the blood levels of Duavee.
NCT02237079 ↗	Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)	Completed	Tulane University Health Sciences Center	Phase 4	2014-12-01	The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.
NCT02274571 ↗	Raising Insulin Sensitivity in Post Menopause	Completed	Pennington Biomedical Research Center	Early Phase 1	2015-09-01	The purpose of this study is to find out if a novel drug approved by the Food and Drug Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by decreasing body fat especially in your liver. DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of postmenopausal women, the use of estrogens alone can increase the risk of developing cancer of the uterus. So estrogens have been traditionally paired with a progestin to decrease the risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place of a progestin to help protect the uterus against thickening of the uterus that may result from estrogens alone. In this study, you will get either DUAVEE™ or the placebo (a "dummy pill" that may look like medicine but contains no active medication) first and then switch to the other pill.
NCT02694809 ↗	The PROMISE Study: Duavee in Women With DCIS	Recruiting	National Cancer Institute (NCI)	Phase 2	2017-01-01	The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
NCT02694809 ↗	The PROMISE Study: Duavee in Women With DCIS	Recruiting	Pfizer	Phase 2	2017-01-01	The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
NCT02694809 ↗	The PROMISE Study: Duavee in Women With DCIS	Recruiting	University of California, San Francisco	Phase 2	2017-01-01	The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.

Clinical Trial Conditions for DUAVEE

Condition Name

Condition Name for DUAVEE
Intervention	Trials
Menopause	3
Obesity	2
Breast Cancer	2
Multiple Sclerosis	1

Condition MeSH

Condition MeSH for DUAVEE
Intervention	Trials
Breast Neoplasms	5
Carcinoma, Intraductal, Noninfiltrating	1
Glucose Intolerance	1
Carcinoma, Ductal, Breast	1

Clinical Trial Locations for DUAVEE

Trials by Country

Trials by Country for DUAVEE
Location	Trials
United States	20

Trials by US State

Trials by US State for DUAVEE
Location	Trials
California	3
Louisiana	3
Kansas	2
Massachusetts	2
Illinois	2

Clinical Trial Progress for DUAVEE

Clinical Trial Phase

Clinical Trial Phase for DUAVEE
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	5
Phase 1	1

Clinical Trial Status

Clinical Trial Status for DUAVEE
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	4
Suspended	1

Clinical Trial Sponsors for DUAVEE

Sponsor Name

Sponsor Name for DUAVEE
Sponsor	Trials
Pfizer	3
Carol Fabian, MD	2
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for DUAVEE
Sponsor	Trials
Other	16
Industry	3
NIH	2

Duavee (conjugated estrogens/bazedoxifene) clinical trials update, market analysis, and exclusivity/patent-driven generic risk

Last updated: May 20, 2026

Duavee (conjugated estrogens, CEE, plus bazedoxifene) sits in the menopausal hormone therapy space with a differentiated dose-combination profile aimed at preventing osteoporosis while avoiding uterine stimulation when used in women with a uterus. Public clinical-trial activity is limited for new registrational studies; the main “update” is post-approval evidence and ongoing real-world utilization, while the market outlook is driven by competitive substitution within estrogen/bazedoxifene alternatives, payer controls, and persistence.

What is the latest clinical-trials update for Duavee (conjugated estrogens bazedoxifene)

Bottom line: Duavee’s registrational program dates to earlier phases; current public sources show no broad late-stage (Phase 3) expansion trials that materially change label or exclusivity posture.

Are there new Phase 3 trials for Duavee

Answer: No widely indexed Phase 3 trial program is evident in current public registries as a label-expanding effort for Duavee. The observable trial footprint tends to be smaller pharmacovigilance, observational, or secondary analyses rather than new endpoints that would rebase exclusivity.

What kinds of studies still appear for Duavee

Answer: The trial mix typically skews toward:

• Observational outcomes in postmenopausal populations
• Adherence and persistence studies in claims databases
• Safety monitoring and rare event surveillance
• Comparisons against other hormone therapy regimens in real-world cohorts

What endpoints dominate Duavee evidence

Answer: Label-aligned outcomes remain the anchor:

• Bone mineral density and fracture risk proxies
• Uterine safety (endometrial effects)
• Vasomotor symptom effects (when evaluated alongside skeletal indications)
• Thromboembolic and cardiovascular safety signals in postmenopausal use contexts

How big is the Duavee market, who buys it, and what drives demand

Bottom line: Duavee’s market is constrained by a niche positioning within hormone therapy and competition from other estrogen-progestin and selective estrogen receptor modulator (SERM) or tissue-selective estrogen complexes. Demand depends on persistence, payer formulary access, and patient selection aligned to uterine safety goals.

Who is the typical Duavee patient

Answer: Postmenopausal women, including those with a uterus, seeking skeletal protection without conventional progestin exposure. Market access often targets:

• Patients with osteoporosis risk who want an estrogenic approach
• Patients for whom uterine safety is a key decision factor
• Clinically stable users who are already adherent

What drives Duavee utilization in practice

Answer: The main levers are:

• Switching cost for stable patients (persistence reduces churn)
• Formulary coverage and prior authorization patterns
• Side-effect tolerability relative to alternatives
• Physician comfort and familiarity with uterine-safety messaging

What is Duavee’s pricing and revenue exposure versus key competitors

Bottom line: Revenue exposure is sensitive to price concessions and rebate dynamics, not just gross unit demand. Duavee’s competitive set includes other branded and generic menopausal hormone therapy regimens, plus SERMs and SERMs-in-combination approaches.

Competitive landscape: where Duavee is compared

Answer: Typical payer and prescriber comparisons include:

• Estrogen-progestin regimens for endometrial protection
• Other SERM-based or tissue-selective estrogen approaches
• Oral bisphosphonate and other osteoporosis therapies that compete for the “bone protection” budget when estrogen use is not strongly preferred

What matters most for future sales

Answer: In this category, the variables that most affect future sales trajectories are:

• Net price trend driven by payer contracting
• Switchability to generics in competing hormone therapy classes
• Uptake of alternative osteoporosis standards of care that reduce demand for estrogen-based options

When does Duavee lose exclusivity and what does the Orange Book say

Bottom line: Duavee is not a drug with a single clean exclusivity “event” visible from label-level public facts; multiple patent layers typically determine practical entry. The Orange Book governs regulatory exclusivity for specific NDA strengths.

Orange Book status

Answer: The Orange Book listing controls whether generic approvals can reference Duavee and whether patents are listed for the drug product, the drug substance, and/or specific manufacturing/use aspects. Without a complete, enumerated list of each listed patent and its expiration date for the specific Duavee NDA/strength, exclusivity timing cannot be stated as a date-certain business fact.

What patents protect Duavee and how strong is the patent estate

Bottom line: Duavee’s protection typically includes a combination of:

• Composition of matter (active ingredient pairing and/or specific salt/chemical definitions)
• Formulation patents for the drug product
• Method-of-use patents around osteoporosis prevention and/or uterine safety claims

Which claim types tend to matter for generic entry

Answer: For combination products, the most consequential barriers usually include:

• Drug product/formulation patents that constrain “equivalence” design for approval
• Method-of-use patents that shape Paragraph IV litigation leverage when label carveouts are needed
• Manufacturing patents tied to process constraints

How to read “strength” for Duavee in licensing or litigation

Answer: For business planning, patent strength should be assessed by:

• Number of listed patents per NDA strength
• Residual life (years left)
• Expected litigation stickiness from prior enforcement or consistent claim drafting
• Likelihood that a generic can design around listed claims without a label compromise that reduces sales

What Paragraph IV challenges are filed for Duavee and how many generics are at risk

Bottom line: A data-complete assessment requires the Orange Book patent-by-patent status and any pending Paragraph IV notices. Without an enumerated notice and litigation docket set, “how many” and “what stage” cannot be stated as a factual count.

What generic entry risks exist for Duavee

Bottom line: The generic risk profile is driven by:

• Whether relevant patents are still listed and enforceable
• Whether generics must pursue label carveouts that reduce commercial value
• Whether formulation or process constraints create practical IP barriers

What would a generic need to do

Answer: A generic version would generally need:

• FDA approval pathway via ANDA referencing the RLD NDA (with patent certifications per Orange Book listings)
• A formulation/process package that supports bioequivalence and meets regulatory equivalence standards
• An agreed label positioning if method-of-use patents require carveouts

Duavee clinical evidence: what outcomes are validated and what is the current medical position

Bottom line: Duavee’s established role is in postmenopausal skeletal protection and uterine safety positioning. Clinical adoption remains linked to patient selection and persistence rather than new label-changing trial evidence.

What outcomes the Duavee label supports

Answer: The label position is anchored to:

• Osteoporosis prevention/treatment-aligned claims (depending on indication wording)
• Endometrial safety with a uterus
• A risk-benefit profile that is used by prescribers to choose it over alternatives

Market projection for Duavee (3-year and 5-year)

Bottom line: The most likely trajectory is steady-to-moderate decline or flat-to-slow growth depending on net price, payer coverage persistence, and substitution pressure from competing hormone therapy and osteoporosis standards of care. A strict quantitative projection requires current baseline units/revenue, which is not provided in the request.

Scenario framework (business-planning format)

Because Duavee’s demand is persistence-driven and sensitive to payer access, projections typically bifurcate into two practical ranges:

Variable	Upside scenario	Base case	Downside scenario
Net price trend	Limited rebate pressure	Moderate contracting	Aggressive rebate/formulary loss
Patient persistence	Stable switch rates	Gradual churn	Faster switching to alternatives
Competitor displacement	Limited	Ongoing substitution	Stronger displacement from other classes
Generic threat	Delayed or narrow entry	Controlled by patent/label	Accelerated substitution if barriers fall

How Duavee compares with competing therapies in clinical positioning

Bottom line: Duavee is typically compared against conventional hormone therapy approaches and osteoporosis drug classes, with the key differentiator being a tissue-selective approach intended to preserve uterine safety while supporting bone-related benefits.

Where Duavee fits in treatment algorithms

Answer: Duavee tends to be considered when clinicians prioritize:

• Skeletal protection goals
• Uterine safety concerns
• Patient preference for non-progestin endometrial management approaches (where appropriate)

Key takeaways

• Duavee’s latest clinically visible updates are not dominated by new late-stage registrational trials; the evidence base remains label-aligned and practice-driven.
• Market performance hinges on payer formulary access, net pricing, and persistence in a niche menopausal hormone therapy segment.
• Generic risk and exclusivity timing depend on the Orange Book patent-by-patent listing and any Paragraph IV activity; those facts must be enumerated to support litigation or entry planning.
• Business projections are scenario-driven: net price and formulary position are typically higher impact than incremental clinical studies.

FAQs

1. Is Duavee still being studied in new Phase 3 trials?
2. What is Duavee’s Orange Book patent list for each strength, and when do listed patents expire?
3. Have any companies filed Paragraph IV ANDAs for Duavee, and what is the litigation timeline?
4. How does Duavee’s uterine safety positioning affect switching versus estrogen-progestin regimens?
5. What would a generic Duavee need for approval and what label carveouts could reduce uptake?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Duavee product listing).
2. ClinicalTrials.gov. Duavee (conjugated estrogens/bazedoxifene) search results.
3. FDA. Drug Approval Package for Duavee (NDA label and review documents).