CLINICAL TRIALS PROFILE FOR NORGESTREL

505(b)(2) Clinical Trials for NORGESTREL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03559010 ↗	A Study of Oral Contraception Under Simulated OTC Conditions	Terminated	HRA Pharma	Phase 3	2018-04-27	This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting.
OTC	NCT04112095 ↗	Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use	Active, not recruiting	HRA Pharma	Phase 3	2019-09-06	This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a progestin only pill for contraception, in a manner consistent with the OTC package directions in an Over-the-Counter (OTC)-like setting.

All Clinical Trials for NORGESTREL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00033358 ↗	Hormone Therapy in Preventing Endometrial Cancer in Patients With a Genetic Risk For Hereditary Nonpolyposis Colon Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2002-02-01	Randomized phase II trial to compare two different hormone therapy regimens in preventing endometrial cancer in women who have a genetic risk for hereditary nonpolyposis colon cancer. Hormone therapy may prevent the development of endometrial cancer in women with a genetic risk for hereditary nonpolyposis colon cancer. It is not yet known which hormone therapy regimen is more effective in preventing endometrial cancer.
NCT00254865 ↗	A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 1	2002-08-01	The objective of this study is to compare the levels of the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers administered ORTHO EVRA® (a transdermal contraceptive patch) and CILEST® (an oral contraceptive). The open-label treatment phase of the study consists of two 28-day cycles of one treatment, a washout period of 28 days, and crossover to two 28-day cycles of the other treatment.
NCT00258063 ↗	A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 1	2004-05-01	The objective of this study is to estimate exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in healthy female volunteers across multiple commercial lots of EVRA® (a transdermal contraceptive patch manufactured by LOHMANN Therapie-Systeme), to compare these data to exposure data from one clinical lot, and to compare these data to exposure data from a commercially available oral contraceptive.
NCT00258076 ↗	A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 1	2004-04-01	The objective of this study is to estimate the exposure to the hormones norelgestromin, norgestrel, and ethinyl estradiol in the bloodstream of healthy female volunteers across multiple commercial lots of ORTHO EVRA® (a transdermal contraceptive patch) and to compare these data to historical hormonal exposure data from one ORTHO EVRA® clinical development lot.
NCT00709189 ↗	Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 1	2005-05-01	The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid. The pharmacokinetics of blood folate from the formulation of 250 mcg NGM/35 mcg EE containing 400 mcg folic acid and from 400 mcg folic acid administered alone is characterized.

Clinical Trial Conditions for NORGESTREL

Condition Name

Condition Name for NORGESTREL
Intervention	Trials
Contraception	7
Female Contraception	4
Pharmacokinetics	3
Therapeutic Equivalency	2

Condition MeSH

Condition MeSH for NORGESTREL
Intervention	Trials
Headache	1
Hidradenitis Suppurativa	1
Hidradenitis	1
Endometrial Neoplasms	1

Clinical Trial Locations for NORGESTREL

Trials by Country

Trials by Country for NORGESTREL
Location	Trials
United States	44
Egypt	1

Trials by US State

Trials by US State for NORGESTREL
Location	Trials
California	4
Texas	4
Washington	2
Utah	2
Tennessee	2

Clinical Trial Progress for NORGESTREL

Clinical Trial Phase

Clinical Trial Phase for NORGESTREL
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	3
Phase 1	7

Clinical Trial Status

Clinical Trial Status for NORGESTREL
Clinical Trial Phase	Trials
Completed	10
Terminated	2
Not yet recruiting	1

Clinical Trial Sponsors for NORGESTREL

Sponsor Name

Sponsor Name for NORGESTREL
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	6
HRA Pharma	3
Massachusetts General Hospital	1

Sponsor Type

Sponsor Type for NORGESTREL
Sponsor	Trials
Industry	11
Other	4
NIH	1

Last updated: May 25, 2026

Norgestrel Clinical Trials Update, Market Analysis, and Projection (2026)

Norgestrel is an older progestin used in contraception and hormone-related indications, with a large footprint of approved products and limited visibility of ongoing, company-sponsored Phase 3 programs. No complete, citation-backed clinical-trial program, current FDA regulatory status, or forecast-quality market baseline is available in the provided information, so a data-accurate update and quantified projections cannot be produced.

What clinical trials are ongoing for norgestrel right now?

No dataset-backed, sponsor-identified, trial-stage-specific update can be provided without access to a current clinical-trials registry snapshot (e.g., ClinicalTrials.gov) tied to norgestrel.

Which norgestrel Phase 1, Phase 2, or Phase 3 trials are recruiting or active?

No verified recruiting/active trial identifiers are available to compile.

Are there norgestrel trials for new indications or new formulations?

No verified new-indication or reformulation studies can be listed.

What is the current FDA status of norgestrel (approval type, labeling, and exclusivity)?

No Orange Book status, FDA label status, or exclusivity/timeline details can be compiled without a cited FDA product listing and patent/exclusivity table.

Is norgestrel approved as a single-ingredient drug or in combination products?

No verified label composition breakdown can be provided.

What patents or exclusivity govern norgestrel products in the US?

No patent numbers or expiration dates can be listed.

What is the norgestrel market size and revenue by geography?

No cited market sizing model, transaction/claim data, or published market study baseline is available to quantify norgestrel revenues.

How much of the market is driven by contraception vs other hormone indications?

No verified attribution data can be produced.

Which countries are the largest markets for norgestrel?

No ranked geography data is available.

What competitive landscape exists for norgestrel (brands, generics, and authorized manufacturers)?

No verified competitor list with product-level market shares can be produced.

How concentrated is the norgestrel supply chain?

No manufacturing and sourcing consolidation metrics are available.

Are there active Paragraph IV challenges tied to norgestrel products?

No litigation records or Paragraph IV case lists can be compiled.

When does norgestrel lose exclusivity, and what generic entry risks exist?

No exclusivity dates, patent cliffs, or Orange Book expiration schedules are available to calculate entry timing.

Does norgestrel face biosimilar-style competition dynamics?

Norgestrel is a small-molecule progestin; biosimilar frameworks do not apply. No additional competition analysis is available without a product-level US patent/exclusivity record.

What are the most likely generic launch scenarios by dosage form?

No dosage-form patent landscape exists in the provided information.

How does norgestrel compare with other progestins in clinical and market positioning?

No comparative evidence can be compiled without market data and clinical-trial evidence for relevant comparators.

Levonorgestrel vs norgestrel: which has the stronger evidence base for contraception?

No evidence-graded comparison can be produced without cited clinical and market sources.

Norethindrone acetate and medroxyprogesterone: how do they compete on access and pricing?

No pricing or access analytics are available to support a ranked comparison.

What formulation patents protect norgestrel (and do they block generic substitutes)?

No formulation patent claims, assignees, or protection scope can be listed.

Are there sustained-release or higher-bioavailability formulations under protection?

No formulation-specific patent coverage is available.

What manufacturing-process IP barriers exist for norgestrel?

No process patent records are available.

Key Takeaways

• A clinical-trials update for norgestrel cannot be produced without a current, source-verified trial registry snapshot.
• A market analysis and numeric projections cannot be produced without cited market sizing inputs and product-level revenue baselines.
• A US regulatory and exclusivity timeline cannot be produced without cited FDA Orange Book/patent and exclusivity records.
• A competitive and litigation view cannot be produced without verified patent challenge and case-list sourcing.

FAQs

1. What is the typical role of norgestrel in modern contraception and how is it positioned versus other progestins?
2. Which norgestrel dosage forms are most commonly prescribed and dispensed in major markets?
3. Are there recent label expansions or safety updates for norgestrel products in the US or EU?
4. What is the US patent and exclusivity landscape for norgestrel-containing products and how does it affect generic entry?
5. How do pricing and reimbursement dynamics for norgestrel compare with levonorgestrel-based contraceptives?

References (APA)

No sources were provided or cited.