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	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.
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.

All Clinical Trials for norgestrel

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.

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

Trials by US State

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−

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	9
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	3
NIH	1

Norgestrel: Clinical Trials, Market Analysis, and Projections

Introduction

Norgestrel, a progestin-only contraceptive, has recently made significant strides in both clinical trials and market approval. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Approval

Rx-to-OTC Switch Trials

The transition of norgestrel from a prescription-only to an over-the-counter (OTC) medication has been facilitated through comprehensive clinical trials. The "OPTION" study, conducted by PEGUS Research, Inc., was a multi-center oral contraceptive pill use trial designed to evaluate the adequacy of OTC labeling in guiding consumer selection and use behavior[1].

• Study Objectives: The primary goal was to assess whether the proposed OTC labeling was sufficient to guide appropriate consumer selection and use of norgestrel 0.075 mg tablets.
• Methodology: The study involved a self-selection (SS) phase followed by an actual use trial (AUT) phase. Participants were required to purchase and use the product, record their medication use, and participate in follow-up interviews.
• Outcomes: The study demonstrated high adherence rates, with 92.5% of participants adhering to daily norgestrel use and 95.7% taking it consistently within a 3-hour window of the previous dose[4].

FDA Approval

In July 2023, the FDA approved Opill (norgestrel) tablets for nonprescription use in the U.S., marking a significant milestone in reproductive health. This approval allows customers to purchase norgestrel without a prescription at various retail outlets, including convenience stores, drug stores, grocery stores, and online platforms[2].

Market Analysis

Global Hormonal Contraceptive Market

The global hormonal contraceptive market is experiencing steady growth, driven by increasing demand for accessible birth control options.

• Market Size: The global hormonal contraceptive market was estimated at USD 16.14 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 4.01% from 2024 to 2030, reaching USD 21.21 billion by 2030[2].
• Regional Dominance: North America dominates the market with a share of 45.41% in 2023, attributed to high per capita income, strong presence of key market players, and higher awareness about sexual health[2].

Segment Performance

The pill segment, which includes norgestrel, dominated the market with a revenue share of 47.44% in 2023. This dominance is due to the simplicity and ease of administration, high efficiency, and better awareness about pills compared to other contraceptive methods[2].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the hormonal contraceptive market, including:

• Increased Accessibility: The approval of norgestrel for OTC use is expected to increase demand by making the product more accessible to a broader population[2].
• Innovation and New Products: Industry players are investing in research and development, leading to the introduction of new products and technologies that meet the rising needs for effective and convenient contraceptives[2].
• Regional Expansion: The market is experiencing significant regional expansion, particularly in the Asia Pacific, Europe, and North America regions, driven by increasing awareness, government initiatives, and demographic shifts[2].

Future Outlook

The hormonal contraceptive market, including norgestrel, is poised for continued growth. Here are some key projections:

• Market Size: The global contraceptive drugs and devices market is expected to reach USD 55.86 billion by 2034, growing at a CAGR of 5.93% from 2024 to 2034[5].
• Regional Growth: The Asia Pacific region is expected to be the largest market, driven by growing penetration in emerging countries and increasing awareness about reproductive health[5].

Impact on Reproductive Health

Accessibility and Convenience

The OTC approval of norgestrel significantly enhances accessibility and convenience for individuals seeking birth control. This shift reduces barriers to obtaining contraception, particularly for those in underserved communities or with limited access to healthcare providers[2].

Public Health Implications

Increased access to effective contraceptives like norgestrel can lead to a reduction in unintended pregnancies, which is a critical public health goal. This can also contribute to better reproductive health outcomes and reduced healthcare costs associated with unplanned pregnancies[2].

Key Takeaways

• Clinical Trials Success: The OPTION study demonstrated the safety and efficacy of norgestrel for OTC use, leading to FDA approval.
• Market Growth: The global hormonal contraceptive market is growing, driven by increased accessibility, innovation, and regional expansion.
• Future Projections: The market is expected to reach USD 21.21 billion by 2030 and USD 55.86 billion by 2034, with the Asia Pacific region leading the growth.
• Public Health Impact: OTC approval of norgestrel enhances accessibility and convenience, contributing to better reproductive health outcomes.

FAQs

What is the current status of norgestrel in the U.S. market?

Norgestrel, under the brand name Opill, has been approved by the FDA for nonprescription use in the U.S. as of July 2023[2].

How does the OTC approval of norgestrel impact reproductive health?

The OTC approval of norgestrel increases accessibility and convenience for individuals seeking birth control, potentially reducing unintended pregnancies and improving reproductive health outcomes[2].

What are the primary endpoints evaluated in the OPTION study for norgestrel?

The primary endpoints included the percentage of days norgestrel was taken (target 85%) and the percentage of days it was taken consistently (target 80%)[4].

Which region is expected to dominate the hormonal contraceptive market in the future?

The Asia Pacific region is expected to be the largest market for hormonal contraceptives, driven by growing penetration in emerging countries and increasing awareness about reproductive health[5].

What is the projected CAGR for the global hormonal contraceptive market from 2024 to 2030?

The global hormonal contraceptive market is expected to grow at a CAGR of 4.01% from 2024 to 2030[2].

Sources

1. PEGUS Research, Inc. - Rx-to-OTC Switch Opill® (norgestrel 0.075 mg) CONFIDENTIAL Actual Use Trial Protocol Final v. 1.2, 15DEC2017
2. Grand View Research - Hormonal Contraceptive Market Size & Share Report, 2030
3. Rett Research & Clinical Pipeline - Explore the latest advancements in Rett syndrome research, clinical trials, and therapies funded by the International Rett Syndrome Foundation.
4. Public Health and Safety Pharmacy - The First FDA Approved OTC Oral Contraceptive Opill
5. Precedence Research - Contraceptive Drugs and Devices Market Size to Hit USD 55.86 Bn ...