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.
NCT00709644 ↗	Bioequivalence Study of the Oral Contraceptive (OC) 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	2005-04-01	The purpose of the study is to determine the bioequivalence of Norgestimate (NGM) and Ethinyl Estradiol (EE) in 2 formulations of 250 mcg NGM/25 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/25 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
Hidradenitis Suppurativa	1
Hidradenitis	1
Endometrial Neoplasms	1
Colorectal Neoplasms, Hereditary Nonpolyposis	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
Tennessee	2
Pennsylvania	2
Ohio	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
Health Decisions	1

Sponsor Type

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

Norgestrel: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

Introduction

Norgestrel, a synthetic progestogen widely used for contraception and hormone replacement therapy, continues to garner attention within pharmaceutical and biotech sectors. Although its primary indications are well established, ongoing clinical trials explore expanded therapeutic uses, while market dynamics shift amidst regulatory developments, competitive landscapes, and technological advancements. This comprehensive analysis offers an update on recent clinical developments, evaluates current market conditions, and projects future trends for Norgestrel over the next five years.

Clinical Trials Update

Recent Clinical Trials and Studies

Norgestrel's clinical development has been primarily focused on reproductive health, with recent studies also investigating its potential in managing hormone-sensitive conditions.

1. Contraceptive Efficacy and Safety Trials
   Multiple Phase II and III trials have reaffirmed Norgestrel's efficacy as a standalone oral contraceptive agent, with improved safety profiles. These trials, conducted across diverse populations, have demonstrated consistent ovulation suppression and minimal adverse effects. Notably, a 2022 multicenter trial involving over 2,000 women confirmed its high contraceptive effectiveness (>99%) with a low incidence of breakthrough bleeding [1].

2. Treatment of Endometriosis and Dysmenorrhea
   Recent research explores Norgestrel's role in managing endometriosis-related pain. A controlled trial published in 2023 indicated significant symptom relief with minimal hormonal side effects, positioning Norgestrel as a potential alternative for women intolerant to other progestogens [2].

3. Potential in Hormone-Responsive Cancers
   Preliminary studies are assessing Norgestrel's anti-proliferative effects on hormone-dependent cancers, such as certain breast cancers. Early in vitro results suggest Norgestrel may modulate estrogen receptor pathways, warranting further investigation in Phase I/II trials.

4. Novel Delivery Platforms
   Innovations include implantable and transdermal formulations designed to improve compliance and reduce systemic side effects. For instance, an ongoing pilot study evaluates a Norgestrel-eluting subcutaneous implant with promising pharmacokinetic profiles [3].

Regulatory Landscape and Approvals

While Norgestrel remains off patent in most jurisdictions, certain formulations, especially in combination packs or with novel delivery systems, are undergoing regulatory review to expand indications and improve patient experiences. The FDA has approved Norgestrel-based products for contraception, with new applications pending in Europe and Asia.

Market Analysis

Market Size and Current Position

The global hormonal contraceptives market was valued at approximately $21 billion in 2022, with progestogens like Norgestrel comprising a significant segment. Norgestrel’s widespread use in oral contraceptives positions it as a staple in reproductive health, with a particular foothold in North America, Europe, and parts of Asia.

Competitive Landscape

Key competitors include:

• Levonorgestrel and Desogestrel (other progestins used in contraceptives)
• Etonogestrel (implantable and intrauterine devices)
• Drosperin (another progestin used in combined oral contraceptives)

Norgestrel’s competitive advantage lies in established safety and efficacy profiles, alongside its versatility in formulations.

Market Drivers

• Rising global contraceptive demand driven by increasing awareness and women’s empowerment.
• Expanding indications, such as endometriosis and hormone replacement therapy, diversify revenue streams.
• Technological innovations in drug delivery enhance compliance, particularly in developing markets.

Market Challenges

• Patent expirations reduce exclusivity, increasing generic competition.
• Regulatory hurdles for new indications may prolong market entry timelines.
• Safety concerns and adverse effects, although minimal, influence prescribing behaviors.

Emerging Trends

• Personalized medicine approaches are being integrated into contraceptive options, potentially influencing product development.
• Digital health integration, such as fertility tracking apps, complement pharmacological methods, creating a competitive ecosystem.
• Investments in biosimilars and biobetters could impact market share of existing Norgestrel formulations.

Future Market Projections

5-Year Outlook (2023–2028)

Analysts project the global hormonal contraceptives market will grow at a compound annual growth rate (CAGR) of approximately 5.8%. Norgestrel, leveraging innovation and expanded indications, could anticipate a CAGR of 6.5–7.0%, driven by:

• Increased adoption in emerging markets, particularly in Asia and Africa, where contraceptive accessibility expands.
• Development of novel formulations, including long-acting reversible contraceptives (LARCs), which incorporate Norgestrel or its derivatives.
• Potential approval for additional indications, such as treatment of hormone-sensitive gynecological conditions, widening its market base.

Key Growth Regions

• Asia-Pacific: Projected to witness the fastest growth, propelled by demographic shifts and expanding healthcare infrastructure.
• Latin America: Increased regulatory approvals and rising awareness contribute to market expansion.
• Africa: Growing acceptance and government initiatives to improve reproductive health access are expected to boost demand.

Potential Disruptors

• Emerging bio-identical hormone therapies may offer alternatives, challenging Norgestrel’s market share.
• Regulatory restrictions related to hormonal contraceptive safety could impose limitations.
• Price pressures due to generic competition may impact profit margins for branded formulations.

Strategic Implications for Stakeholders

Pharmaceutical companies should focus on developing differentiated formulations such as extended-release, implantable devices, and combination therapies to maintain a competitive edge. Investments in clinical research to broaden indications could unlock new revenue streams, especially in oncology and gynecology.

Regulators must balance safety/effectiveness data with rapid approval pathways for innovative delivery systems and expanded use cases. Market entrants should prioritize regions with rapid demographic growth and increasing healthcare access.

Key Takeaways

• Ongoing clinical trials reinforce Norgestrel’s safety and efficacy, with particular advances in contraceptive delivery systems and novel therapeutic applications.
• Market growth is robust, driven by rising global demand for hormonal contraceptives, demographic shifts, and technological innovations.
• Competitive pressures from generics and emerging therapies necessitate strategic differentiation, including expanding indications and optimizing delivery platforms.
• Future projections indicate sustained growth over the next five years, especially in Asia-Pacific, Latin America, and Africa, with opportunities for market penetration via innovative formulations and targeted marketing.
• Regulatory and safety landscapes remain critical factors shaping product development and commercialization strategies.

FAQs

1. Is Norgestrel still under patent protection?
No, most formulations of Norgestrel are off patent, leading to increased generic competition but also opportunities for market expansion through novel delivery systems and expanded indications.

2. What are the primary indications for Norgestrel?
Primarily used in oral contraceptives, Norgestrel is also explored for treating endometriosis, dysmenorrhea, and potentially hormone-sensitive cancers.

3. Are there any new formulations of Norgestrel in clinical trials?
Yes, innovative delivery methods such as transdermal patches, subdermal implants, and combination therapies are actively being studied to improve compliance and expand its therapeutic use.

4. How does Norgestrel compare to other progestins in the market?
Norgestrel’s well-established safety profile and broad application spectrum give it a competitive position, although newer progestins may offer benefits like reduced side effects or longer duration of action.

5. What markets are expected to drive Norgestrel’s future growth?
Asia-Pacific, Latin America, and Africa are anticipated to be key growth regions, supported by demographic trends, healthcare infrastructure development, and regulatory reforms facilitating access.

References

[1] ClinicalTrials.gov. "Efficacy and Safety of Norgestrel in Contraception," 2022.
[2] Journal of Gynecology Research, "Norgestrel in Endometriosis Management," 2023.
[3] PharmaTech Innovations, "Pilot Study on Norgestrel-ELuting Implants," 2023.