CLINICAL TRIALS PROFILE FOR FEMHRT

All Clinical Trials for FEMHRT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00600106 ↗	Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study	Completed	Allegheny University	N/A	1999-12-01	The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. The main trial duration: December 1999 - May 2003. The ancillary data analysis project duration: April 2006 - March 2010.
NCT00600106 ↗	Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study	Completed	Johns Hopkins University	N/A	1999-12-01	The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. The main trial duration: December 1999 - May 2003. The ancillary data analysis project duration: April 2006 - March 2010.
NCT00600106 ↗	Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study	Completed	Parke-Davis	N/A	1999-12-01	The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. The main trial duration: December 1999 - May 2003. The ancillary data analysis project duration: April 2006 - March 2010.
NCT00600106 ↗	Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study	Completed	University of Alabama at Birmingham	N/A	1999-12-01	The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. The main trial duration: December 1999 - May 2003. The ancillary data analysis project duration: April 2006 - March 2010.
NCT00600106 ↗	Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study	Completed	University of Florida	N/A	1999-12-01	The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. The main trial duration: December 1999 - May 2003. The ancillary data analysis project duration: April 2006 - March 2010.

Clinical Trial Conditions for FEMHRT

Condition Name

Condition Name for FEMHRT
Intervention	Trials
Myocardial Ischemia	1

Condition MeSH

Condition MeSH for FEMHRT
Intervention	Trials
Myocardial Ischemia	1
Ischemia	1
Coronary Artery Disease	1

Clinical Trial Locations for FEMHRT

Trials by Country

Trials by Country for FEMHRT
Location	Trials
United States	1

Trials by US State

Trials by US State for FEMHRT
Location	Trials
California	1

Clinical Trial Progress for FEMHRT

Clinical Trial Phase

Clinical Trial Phase for FEMHRT
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for FEMHRT
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for FEMHRT

Sponsor Name

Sponsor Name for FEMHRT
Sponsor	Trials
University of Alabama at Birmingham	1
University of Florida	1
University of Pittsburgh	1

Sponsor Type

Sponsor Type for FEMHRT
Sponsor	Trials
Other	6
Industry	1

Last updated: May 22, 2026

FEMHRT clinical trials update, patent and market projection (2026)

FEMHRT (estradiol + norethindrone acetate tablets, USP) is a legacy HRT combination with ongoing lifecycle risk from generics and from patent-expiration timing across reformulations. Current drug-level market exposure is driven by (1) persistence of brand demand in WHI-era replacement regimens, (2) formulary restrictions and payer step-therapy, and (3) the availability of AB-rated generic equivalents.

Because “FEMHRT” is an established, small-molecule oral combination product and not a single new molecular entity, the clinical-trials landscape largely reflects post-marketing observational studies and comparative bioequivalence rather than large phase 3 programs. A full, decision-grade “clinical trials update” and “market projection” requires verified, time-stamped sourcing for active trials and for current U.S. prescribing and sales, including Orange Book exclusivity and patent expiration events. No such verified dataset is provided here, so a complete and accurate update cannot be produced.

What clinical trials are ongoing for FEMHRT in 2026?

Answer: No decision-grade ongoing trials can be confirmed without time-stamped registry data (ClinicalTrials.gov or EUCTR) and without an explicit trial list tied to the branded name “FEMHRT” versus generic equivalents (estradiol/norethindrone acetate).

What trial types typically appear for FEMHRT-like legacy HRT?

• Bioequivalence and PK/PD studies for generic substitution
• Post-marketing observational cohorts and real-world adherence studies
• Safety surveillance updates (endometrial bleeding, VTE, breast cancer incidence in long-term users)

How to interpret “FEMHRT” listings versus generic estradiol/norethindrone acetate

HRT combo studies may be indexed under:

• “estradiol and norethindrone acetate”
• “combined estrogen-progestin”
• specific dose strengths (e.g., 0.5 mg/2.5 mg or 1.0 mg/5 mg, depending on the labeled strengths)

What is the FEMHRT market size and who drives demand?

Answer: No verified market-size or prescribing-base figures are available in the prompt to support a defensible market analysis.

Demand drivers that usually matter for oral combined estrogen-progestin HRT

• Menopausal symptom control in midlife and older women
• Payer formulary positioning after generic substitution
• Clinician and patient preferences for dosing schedules and tablet size
• Switching patterns to transdermal products when VTE risk concerns tighten

Competitive substitute set

FEMHRT’s practical competition is usually:

• AB-rated generic estradiol/norethindrone acetate tablets
• Other oral combined HRT regimens (alternative progestins)
• Transdermal options (lower systemic exposure profiles in some clinical perceptions)

When does FEMHRT lose exclusivity or face generic entry risk?

Answer: No Orange Book exclusivity or patent-expiration schedule is provided in the prompt to determine exact loss dates for FEMHRT brand exclusivity, method-of-use protection, or formulation/packaging patents.

What typically determines exclusivity for legacy HRT brands

• Granted composition-of-matter or formulation patents
• Method-of-use patents (dose regimen, patient subgroup indications)
• FDA exclusivity periods (patent term adjustments, pediatric exclusivity, or exclusivity tied to supplements)

What “generic entry risk” depends on in practice

• Whether patents are listed for specific label indications and strengths
• Whether Paragraph IV ANDA challenges exist for listed patents
• Whether 30-month stay occurred and expired for relevant strengths

What patent estate protects FEMHRT and how strong is it?

Answer: No patent numbers, assignees, listed Orange Book entries, or expiration dates are provided in the prompt, so a complete patent-estate strength analysis cannot be produced.

What to map for a litigation-grade estate review

• Orange Book listing by NDA holder and strength
• Patent families (composition, formulation, method of use)
• Expiration by jurisdiction (US only is typical for U.S. generics)
• Litigation history (district court, ITC, appellate)

How does FEMHRT compare with other estradiol/norethindrone acetate regimens?

Answer: No specific comparator strengths, dosing schedules, or clinical outcome claims are provided, so a decision-grade comparison is not possible from the prompt alone.

Parameters that typically decide payer and prescriber choice

• Dose strength availability and titration schedule
• Tablet burden and tolerability
• Formulary tier placement after generic entry
• Real-world adherence patterns

What Paragraph IV challenges or FDA Orange Book status affect FEMHRT?

Answer: No Orange Book status, listed patents, or ANDA challenge history is provided, so Paragraph IV and settlement risk cannot be quantified.

What you would normally extract for a FEMHRT risk model

• Listed patents per strength and their expiration dates
• Whether ANDAs filed with Paragraph IV certification
• Settlement triggers (non-infringement findings, “no entry until” dates)
• Current label match and AB-rating for generics

What is the regulatory status of FEMHRT and its generic pathway?

Answer: No verified FDA regulatory information is provided in the prompt to define:

• Current NDA status (active, discontinued, or limited distribution)
• Whether approved generics are AB-rated and launched by strength
• Any recent label changes affecting substitution

How many brands and generics are on the FEMHRT market and what share do they hold?

Answer: No verified product list and market-share split is provided in the prompt.

The market structure you would typically expect

• One or more FDA-approved generic manufacturers per strength
• Brand shrinking or stable only in niche formularies, depending on payer rebates and substitution rules
• Switching to competing HRT categories when formularies tighten

Market projection for FEMHRT through 2030: scenarios and assumptions

Answer: A quantified projection cannot be constructed without:

• Current baseline U.S. sales (or prescriptions)
• Current generic utilization split
• Any newly relevant patent events, settlements, or formulary restrictions
• Date-stamped clinical-trials or regulatory milestones affecting supply/demand

Scenario framework (what drives the model once baseline data exists)

• Base case: continued generic substitution and stable unit demand for oral combined HRT
• Downside: further payer restrictions, accelerated switch to alternative delivery systems, stronger safety-driven discontinuation
• Upside: higher adherence due to dosing convenience, localized brand retention under rebate dynamics, or supply disruptions among generics

Key Takeaways

• FEMHRT is a legacy oral combined estrogen-progestin regimen where clinical-trials activity is usually post-marketing or bioequivalence focused rather than large late-stage development.
• A decision-grade clinical update, patent expiration map, Paragraph IV landscape, and quantified market forecast cannot be produced from the information provided.
• Any accurate projection through 2030 requires time-stamped FDA/Orange Book and sales/prescribing baseline data tied to branded and AB-rated equivalents by strength.

FAQs

1. Are there new phase 3 trials for FEMHRT in menopausal symptom management?
2. Does FEMHRT have listed patents in the FDA Orange Book for each strength and progestin dose?
3. How often do estradiol/norethindrone acetate ANDAs file Paragraph IV certifications for listed patents?
4. What are the typical switching patterns from oral combined HRT like FEMHRT to transdermal options?
5. Which safety endpoints most influence payer restrictions for long-term combined HRT prescriptions?

References

No sources were provided in the prompt, and no verifiable external datasets were cited.