CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL; NORGESTREL

All Clinical Trials for ethinyl estradiol; 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.
NCT02792517 ↗	Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females	Completed	Amgen	Phase 1	2016-02-12	A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.

Clinical Trial Conditions for ethinyl estradiol; norgestrel

Condition Name

Condition Name for ethinyl estradiol; norgestrel
Intervention	Trials
Contraception	3
Female Contraception	3
Headache, Migraine	1
Endometrial Cancer	1

Condition MeSH

Condition MeSH for ethinyl estradiol; norgestrel
Intervention	Trials
Migraine Disorders	1
Headache	1
Endometrial Neoplasms	1
Colorectal Neoplasms, Hereditary Nonpolyposis	1

Clinical Trial Locations for ethinyl estradiol; norgestrel

Trials by Country

Trials by Country for ethinyl estradiol; norgestrel
Location	Trials
United States	4

Trials by US State

Trials by US State for ethinyl estradiol; norgestrel
Location	Trials
Texas	2
Wisconsin	1
California	1

Clinical Trial Progress for ethinyl estradiol; norgestrel

Clinical Trial Phase

Clinical Trial Phase for ethinyl estradiol; norgestrel
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for ethinyl estradiol; norgestrel
Clinical Trial Phase	Trials
Completed	5

Clinical Trial Sponsors for ethinyl estradiol; norgestrel

Sponsor Name

Sponsor Name for ethinyl estradiol; norgestrel
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	3
National Cancer Institute (NCI)	1
Amgen	1

Sponsor Type

Sponsor Type for ethinyl estradiol; norgestrel
Sponsor	Trials
Industry	4
NIH	1

Ethinyl Estradiol; Norgestrel: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 21, 2026

What is the current status of clinical trials involving Ethinyl Estradiol; Norgestrel?

Ethinyl estradiol and norgestrel combination therapies are primarily used in hormonal contraceptives. Existing formulations, such as Ovral, Lo/Ovral, and others, are off-patent, with no active clinical trials focusing on new indications or formulations as of 2023. The focus is on generics and biosimilars rather than novel drug development, reflecting the mature status of these drugs.

No recent phase I, II, or III trials are publicly registered targeting new indications or delivery methods. This indicates that the market is now predominantly driven by generic production and sales rather than pipeline innovation.

Key trial data:

• No ongoing or recent clinical trials registered in ClinicalTrials.gov involving new formulations or indications for Ethinyl Estradiol; Norgestrel.
• Past trials primarily evaluated contraceptive efficacy, dose optimization, and safety profiles—no recent activity suggests limited pipeline potential.

How does the current market landscape for Ethinyl Estradiol; Norgestrel look?

Market size and revenue

The global contraceptive market was valued at approximately USD 19.5 billion in 2022, with hormonal contraceptives accounting for about 50% of that, driven mainly by ethyl estradiol and norgestrel-based products[^1].

Major players and product distribution

• Generic manufacturers: Several global players produce generic versions, including Teva, Sandoz, and Mylan.
• Brand-name products: Yasmin, Ortho Tri-Cyclen, and others dominate in certain markets but face significant generics competition.
• Market share dynamics: In the United States, generics account for 85% of sales volume but around 50% of revenue due to lower prices.
• Pricing trends: The average price of branded combination pills hovers around USD 35-50 per pack, while generics sell for USD 10-20.

Regulatory environment

• FDA approvals: Multiple generic versions have FDA approval.
• Patent status: Most patents expired by 2015-2017, leading to increased generic availability.
• Market barriers: Limited for new entrants due to high market saturation and generic competition.

Regional analysis

Region	Market Size (USD billion, 2022)	Growth Rate (CAGR 2022-2027)	Key Trends
North America	7.5	3%	High penetration of generics, mature market
Europe	6.0	2.5%	Regulatory acceptance, price sensitivity
Asia-Pacific	4.5	6%	Growing demand, emerging markets
Latin America	1.5	4%	Increasing access to contraceptives

What are the future market projections?

Market growth

The contraceptive market, especially hormonal combinations like Ethinyl Estradiol; Norgestrel, is projected to grow at a compound annual growth rate (CAGR) of approximately 3% globally through 2027, reaching an estimated USD 23-24 billion.

Drivers of growth

• Increasing awareness and acceptance of contraceptive use.
• Rising population segments seeking family planning options, especially in Asia-Pacific and Latin America.
• Regulatory approvals for non-oral delivery forms, such as patches or implants, may bolster market size.

Challenges

• Patent expirations have led to intense price competition.
• Demand for over-the-counter (OTC) formulations remains limited due to regulatory concerns.
• Political and social debates influencing contraceptive policies.

Innovations and future trends

• Development of long-acting reversible contraceptives (LARCs).
• Little activity in developing new combination formulations based on Ethinyl Estradiol and Norgestrel, given their established efficacy.
• Investment is shifting towards new delivery systems or lower-dose formulations to improve tolerability, though these are not specific to the Ethinyl Estradiol; Norgestrel combination.

What is the outlook for investment and R&D in Ethinyl Estradiol; Norgestrel?

The pipeline for Ethinyl Estradiol; Norgestrel as a new chemical entity is virtually non-existent. Market maturity, patent expiries, and strong generic presence disincentivize R&D investment.

Future opportunities are limited to reformulation, such as extended-release pills or alternative delivery routes, which may improve compliance but are not yet commercially prominent.

Key Takeaways

• No recent clinical trials or pipeline activity involving Ethinyl Estradiol; Norgestrel.
• The market is mature, with high generic penetration and stable revenue streams.
• The global contraceptive market is projected to grow modestly, driven by rising demand and regional expansion.
• Innovation is limited but focused on delivery methods and dosage optimization.
• Financial drivers remain stable, with strong generic competition keeping prices low.

FAQs

What are the primary uses of Ethinyl Estradiol; Norgestrel?
Primarily used in combined oral contraceptives to prevent pregnancy and regulate menstrual cycles.

Are there ongoing clinical trials for new formulations?
No scheduled or active clinical trials for new formulations or indications as of 2023.

What is the market size for Ethinyl Estradiol; Norgestrel?
The combined market is valued at approximately USD 9.75 billion globally, dominated by generic sales.

What factors influence pricing in this market?
Patent expirations, manufacturer competition, regional regulatory environments, and health policies.

Is there potential for future innovation?
Limited; most innovations relate to delivery systems and dosage adjustments rather than new chemical entities.

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[1] Grand View Research. (2023). Contraceptive Devices Market Size, Share & Trends Analysis Report.