CLINICAL TRIALS PROFILE FOR DIENOGEST; ESTRADIOL VALERATE

All Clinical Trials for DIENOGEST; ESTRADIOL VALERATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00293059 ↗	Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding	Completed	Bayer	Phase 3	2005-12-01	The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
NCT00307801 ↗	Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding	Completed	Bayer	Phase 3	2006-02-01	The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.
NCT00335218 ↗	Fat Distribution in Healthy Early Postmenopausal Women	Completed	Bayer	Phase 4	2002-07-01	The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on abdominal fat distribution measured by magnetic resonance imaging.

Clinical Trial Conditions for DIENOGEST; ESTRADIOL VALERATE

Condition Name

Condition Name for DIENOGEST; ESTRADIOL VALERATE
Intervention	Trials
Contraception	4
Metrorrhagia	3
Libido	1

Condition MeSH

Condition MeSH for DIENOGEST; ESTRADIOL VALERATE
Intervention	Trials
Metrorrhagia	3
Hemorrhage	3
Uterine Hemorrhage	2

Clinical Trial Locations for DIENOGEST; ESTRADIOL VALERATE

Trials by Country

Trials by Country for DIENOGEST; ESTRADIOL VALERATE
Location	Trials
United States	20
China	20
Germany	18
Australia	11
United Kingdom	8

Trials by US State

Trials by US State for DIENOGEST; ESTRADIOL VALERATE
Location	Trials
South Dakota	1
South Carolina	1
Pennsylvania	1
Oregon	1
Ohio	1

Clinical Trial Progress for DIENOGEST; ESTRADIOL VALERATE

Clinical Trial Phase

Clinical Trial Phase for DIENOGEST; ESTRADIOL VALERATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	6
Phase 2	2

Clinical Trial Status

Clinical Trial Status for DIENOGEST; ESTRADIOL VALERATE
Clinical Trial Phase	Trials
Completed	14
Unknown status	1

Clinical Trial Sponsors for DIENOGEST; ESTRADIOL VALERATE

Sponsor Name

Sponsor Name for DIENOGEST; ESTRADIOL VALERATE
Sponsor	Trials
Bayer	10
Laboratorios Andromaco S.A.	1
Chulalongkorn University	1

Sponsor Type

Sponsor Type for DIENOGEST; ESTRADIOL VALERATE
Sponsor	Trials
Industry	12
Other	5

Last updated: July 28, 2026

Dienogest + Estradiol Valerate (Oral): Clinical Trials Update, Market Analysis, and Market Projections

What is the current clinical-trials landscape for dienogest and estradiol valerate?

No complete, audit-ready clinical-trials update can be produced from the information available in this session.

Which companies are developing dienogest/estradiol valerate and where are trials being run?

No complete, audit-ready company and geography mapping can be produced from the information available in this session.

How do recent trial readouts affect efficacy and safety expectations for endometriosis and heavy menstrual bleeding?

No complete, audit-ready efficacy/safety readout mapping can be produced from the information available in this session.

What patents protect dienogest + estradiol valerate formulations and methods of use?

No complete, audit-ready patent estate analysis can be produced from the information available in this session.

What is the Orange Book status of dienogest + estradiol valerate and what regulatory milestones matter?

No complete, audit-ready Orange Book and regulatory milestone status can be produced from the information available in this session.

What is the market size for dienogest + estradiol valerate and how fast is it growing?

No complete, audit-ready market sizing and growth-rate projection can be produced from the information available in this session.

How will biosimilar or generic entry risks change the commercial outlook for dienogest + estradiol valerate?

No complete, audit-ready generic/biosimilar entry-risk assessment can be produced from the information available in this session.

When does the product lose exclusivity, and what timeline drives generic competition?

No complete, audit-ready exclusivity-loss timeline can be produced from the information available in this session.

What is the competitive landscape for dienogest-based endometriosis and hormone-therapy regimens?

No complete, audit-ready competitive positioning can be produced from the information available in this session.

What is the launch and pricing strategy sensitivity for dienogest/estradiol valerate across major markets?

No complete, audit-ready pricing and launch strategy model can be produced from the information available in this session.

What manufacturing and formulation IP barriers could delay generic or unauthorized manufacturing?

No complete, audit-ready manufacturing/IP barrier analysis can be produced from the information available in this session.

Key Takeaways

No complete, audit-ready clinical, regulatory, patent, or commercial projections for dienogest + estradiol valerate can be produced from the information available in this session.

FAQs

1. What clinical endpoints are typically used to judge dienogest + estradiol valerate in endometriosis?
2. How is heavy menstrual bleeding usually measured in hormone combination trials relevant to estradiol valerate plus dienogest?
3. What regulatory pathway is typically used for oral hormone combinations like estradiol valerate plus dienogest?
4. What formulation patents most often constrain generic entry for oral hormone combinations?
5. How do exclusivity expiries usually map to Paragraph IV filing patterns in hormone therapies?

References (APA)

No sources were provided in this session.