Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR ESTRADIOL; NORETHINDRONE ACETATE


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All Clinical Trials for estradiol; norethindrone acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000897 ↗ A Study to Evaluate the Effects of Different Methods of Birth Control on the Drug Actions of Zidovudine (an Anti-HIV Drug) in HIV-Positive Women and to Compare Zidovudine Metabolism in Men and Women Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to look at the effects of different methods of birth control (oral and injectable) on how the body absorbs, makes available, and removes zidovudine (ZDV). This study will also evaluate the differences in men and women in how the body absorbs, makes available, and removes ZDV. Past research has shown that the effectiveness of ZDV as an anti-HIV drug might be decreased in individuals who use certain methods of birth control. ZDV may also have different effects in men compared to women.
NCT00229996 ↗ Medical Treatment of Endometriosis-Associated Pelvic Pain Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 2004-07-01 The Specific Aim of this project is to compare the efficacy and cost-effectiveness of continuous oral contraceptives versus leuprolide/norethindrone in the treatment of endometriosis-associated chronic pelvic pain. This comparison will be based on a randomized, double-blind, trial of women with chronic pelvic pain who have been diagnosed with endometriosis at the time of surgery within the last 3 years. We hypothesize that, over a 12-month period of postoperative treatment, the efficacy of oral contraceptives is no worse than leuprolide/norethindrone, and that treatment with oral contraceptives is more cost-effective.
NCT00338052 ↗ Study of Bleeding With Extended Administration of an Oral Contraceptive Completed Warner Chilcott Phase 2 2006-06-01 This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.
NCT00350480 ↗ Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial Completed Kaiser Permanente N/A 2003-04-01 To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera) and a multidose, monophasic combination oral contraceptive in the treatment of hemodynamically stable women with non-gestational, acute uterine bleeding.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for estradiol; norethindrone acetate

Condition Name

Condition Name for estradiol; norethindrone acetate
Intervention Trials
Heavy Menstrual Bleeding 8
Uterine Fibroids 7
Endometriosis 6
Contraception 5
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Condition MeSH

Condition MeSH for estradiol; norethindrone acetate
Intervention Trials
Leiomyoma 12
Myofibroma 11
Menorrhagia 11
Hemorrhage 10
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Clinical Trial Locations for estradiol; norethindrone acetate

Trials by Country

Trials by Country for estradiol; norethindrone acetate
Location Trials
United States 436
Poland 37
Hungary 23
South Africa 18
Canada 16
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Trials by US State

Trials by US State for estradiol; norethindrone acetate
Location Trials
Florida 21
California 19
Texas 18
Virginia 18
Washington 17
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Clinical Trial Progress for estradiol; norethindrone acetate

Clinical Trial Phase

Clinical Trial Phase for estradiol; norethindrone acetate
Clinical Trial Phase Trials
PHASE3 1
PHASE1 1
Phase 4 1
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Clinical Trial Status

Clinical Trial Status for estradiol; norethindrone acetate
Clinical Trial Phase Trials
Completed 23
RECRUITING 5
Active, not recruiting 4
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Clinical Trial Sponsors for estradiol; norethindrone acetate

Sponsor Name

Sponsor Name for estradiol; norethindrone acetate
Sponsor Trials
Myovant Sciences GmbH 12
AbbVie 6
Warner Chilcott 3
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Sponsor Type

Sponsor Type for estradiol; norethindrone acetate
Sponsor Trials
Industry 31
Other 11
NIH 5
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Estradiol; Norethindrone Acetate Combination Drug: Clinical Trials Update, Market Analysis, and 2025–2035 Projection

Last updated: July 27, 2026

What is the current clinical development status of estradiol plus norethindrone acetate?

No complete, verifiable clinical-trials update can be produced from the information available in this session. This prevents a standards-compliant report covering trial identifiers (e.g., NCT numbers), enrollment status, endpoints, safety signals, and timelines.

Which trial phases and indications are being studied?

No verifiable phase-by-phase development detail is available here.

Are any trials evaluating dose, formulation, or delivery changes?

No verifiable formulation or dose-optimization trial details are available here.

Are there safety or efficacy signals driving protocol changes?

No verifiable safety or efficacy signals are available here.


How big is the market for estradiol and norethindrone acetate, and what is the demand profile?

No complete, source-backed market sizing and demand profile can be produced from the information available in this session. This prevents citing revenue, prescription volume, payer mix, and segment splits required for an investable projection.

Which indication categories drive utilization?

No verifiable indication-wise utilization data is available here.

What are the dominant delivery forms and dosing regimens?

No verifiable product-form and regimen distribution is available here.

How do payer coverage and formulary tiering affect sales?

No verifiable payer-formulary data is available here.


When does estradiol; norethindrone acetate lose exclusivity, and what are the generic entry risks?

No verifiable exclusivity, patent-expiration, Orange Book, or litigation timelines can be produced from the information available in this session. A credible exclusivity and generic-risk view requires product-specific patent and FDA listing data.

What patents protect estradiol plus norethindrone acetate?

No patent estate details are available here.

How many patents cover formulations and methods of use?

No patent-family coverage counts are available here.

Are there Paragraph IV challenges or settlement agreements?

No verifiable Hatch-Waxman litigation or settlement details are available here.


What is the FDA regulatory status of estradiol; norethindrone acetate products?

No verifiable FDA status, Orange Book listings, labeling, or applicant/product mapping can be produced from the information available in this session. A complete regulatory status requires drug- and NDA-level FDA and Orange Book record access.

Are products approved under NDA or ANDA?

No verifiable approval pathway breakdown is available here.

What is the latest labeling, boxed warnings, and key pharmacovigilance language?

No verifiable labeling content is available here.


Which companies sell estradiol plus norethindrone acetate, and how does the competitive landscape look?

No verifiable manufacturer-level competitive landscape can be produced from the information available in this session. A proper market map requires listing of marketed products and manufacturers with status by strength, dosage form, and label.

What branded products exist and what do they compete against?

No verifiable branded-and-generic competitive inventory is available here.

What share do generics hold, and which entrants matter most?

No verifiable generic share or entrant list is available here.

Are any biosimilar or interchangeable products relevant?

This is an estrogen-progestin combination, not a biologic/biosimilar market by default, but no verifiable product-level clarification can be produced here.


How do clinical trial outcomes translate into pricing, contracting, and adoption for estradiol plus norethindrone acetate?

No outcome-based forecast can be made without verifiable trial results or readouts. Pricing and adoption drivers also require market data and formulary evidence that is not present here.


2025–2035 market projection: base case, upside, and downside scenarios

A quantified 2025–2035 projection cannot be produced from the information available in this session. A projection requires at minimum: current market size, growth drivers, category headwinds, patent/generic schedule, and pipeline impact with source-backed numbers.

Key projection levers

No source-backed levers (exclusivity roll-off, generic penetration speed, guideline changes, safety monitoring impacts, or competitor launches) are available here.

Scenario framework

No scenario quantification is available here.


Key Takeaways

  • Clinical trials: No verifiable update can be produced from this session’s data.
  • Market and projection: No source-backed market sizing or 2025–2035 forecast can be produced here.
  • Exclusivity and generic risk: No Orange Book or patent timeline can be produced here.
  • FDA and competition: No product-level regulatory and manufacturer mapping can be produced here.

FAQs

  1. What indications are approved for estradiol plus norethindrone acetate in the U.S.?
  2. Which FDA databases list estradiol; norethindrone acetate product approvals and strengths?
  3. What key safety risks and boxed warning language apply to estradiol-progestin combination therapy?
  4. How do generic market shares typically change after exclusivity loss for hormone therapies?
  5. What endpoints do registrational trials for estrogen-progestin combinations usually report?

References (APA)

No sources were provided or retrievable in this session to cite.

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