CLINICAL TRIALS PROFILE FOR ETHINYL ESTRADIOL; NORELGESTROMIN

All Clinical Trials for Ethinyl Estradiol; Norelgestromin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00163072 ↗	Pharmacokinetics and Safety of Transdermal Megestrol Acetate	Withdrawn	Milton S. Hershey Medical Center	Phase 4	2005-10-01	Rationale: Megestrol acetate (Megace®) is a progestin analog that is FDA approved for the palliative treatment of breast and endometrial carcinoma. It is also commonly used as an appetite stimulant, particularly in HIV and cancer patients with poor appetite from their primary disease and/or their therapy. Megace is well absorbed orally, however, many patients, particularly younger ones have difficulty taking oral medications. Transdermal progestins are available and are FDA approved. For example, Ortho EvraTM is a transdermal contraceptive patch containing an estrogen (ethinyl estradiol) and a progestin (norelgestromin). Key Objectives: Compare the pharmacokinetics of orally administered vs. transdermal Megace and determine if there are any local side effects of the transdermal route.
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.
NCT00261482 ↗	Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.	Completed	Janssen Pharmaceutica N.V., Belgium	Phase 4	2003-07-01	The purpose of the study is to evaluate user experience with the EVRA® Contraceptive Transdermal Patch; specifically, user satisfaction with the EVRA® Patch, and if applicable, user preference of the EVRA® Patch compared with the previous method of contraception. The study also evaluates contraceptive efficacy, safety and user compliance.

Clinical Trial Conditions for Ethinyl Estradiol; Norelgestromin

Condition Name

Condition Name for Ethinyl Estradiol; Norelgestromin
Intervention	Trials
Contraception	9
Female Contraception	8
Healthy	3
Metrorrhagia	1

Condition MeSH

Condition MeSH for Ethinyl Estradiol; Norelgestromin
Intervention	Trials
Venous Thromboembolism	2
Thromboembolism	2
Hepatitis C	1
Metrorrhagia	1

Clinical Trial Locations for Ethinyl Estradiol; Norelgestromin

Trials by Country

Trials by Country for Ethinyl Estradiol; Norelgestromin
Location	Trials
United States	9
Netherlands	2
Belgium	2
Germany	1

Trials by US State

Trials by US State for Ethinyl Estradiol; Norelgestromin
Location	Trials
Florida	1
Wisconsin	1
Texas	1
California	1
Massachusetts	1

Clinical Trial Progress for Ethinyl Estradiol; Norelgestromin

Clinical Trial Phase

Clinical Trial Phase for Ethinyl Estradiol; Norelgestromin
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Ethinyl Estradiol; Norelgestromin
Clinical Trial Phase	Trials
Completed	16
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for Ethinyl Estradiol; Norelgestromin

Sponsor Name

Sponsor Name for Ethinyl Estradiol; Norelgestromin
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	7
Janssen Research & Development, LLC	3
University of Vermont Medical Center	1

Sponsor Type

Sponsor Type for Ethinyl Estradiol; Norelgestromin
Sponsor	Trials
Industry	17
Other	7

Ethinyl Estradiol and Norelgestromin: Clinical Trials, Market Analysis, and Projections

Introduction

Ethinyl estradiol and norelgestromin are key components of combined hormonal contraceptives, particularly in the form of transdermal patches. These hormones have been extensively studied and used for their efficacy in preventing pregnancy, as well as their impact on women's health. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Update

Ongoing and Recent Studies

A significant ongoing clinical trial involves the evaluation of the safety and efficacy of MR-100A-01, a transdermal delivery system (TDS) containing norelgestromin 4.86 mg and ethinyl estradiol 0.264 mg. This Phase 3 study aims to assess the contraceptive efficacy, cycle control, safety, and tolerability of MR-100A-01 in approximately 1200 healthy women over up to 13 cycles[1].

Another notable study focuses on the use of norelgestromin and ethinyl estradiol in a transdermal system, which has been shown to be effective in preventing pregnancy. This system involves applying a new patch every week for three weeks, followed by a patch-free week. The study highlights that this method may be less effective in women weighing 90 kg or more[4][5].

Safety and Efficacy Findings

Clinical trials have consistently shown that norelgestromin and ethinyl estradiol transdermal systems are effective in preventing pregnancy, with a Pearl Index of 0.90, indicating a low rate of unwanted pregnancies. However, these studies also point out potential risks such as increased venous thromboembolic events, particularly in women with a BMI ≥ 30 kg/m² or those who smoke[4][5].

Cycle Control and Tolerability

The norelgestromin and ethinyl estradiol combination has been found to provide good cycle control, with minimal disruptions in menstrual cycles. However, some women may experience breakthrough bleeding or spotting, especially during the initial cycles. The tolerability of this combination is generally good, although some women may report skin irritation or other minor side effects associated with the patch[4][5].

Market Analysis

Current Market Landscape

The market for hormonal contraceptives is diverse, with various formulations available, including oral pills, patches, vaginal rings, and implants. The norelgestromin and ethinyl estradiol transdermal patch, marketed under names like Evra, holds a significant position due to its convenience and adherence benefits compared to daily oral contraceptives.

Market Trends

There is a growing demand for non-oral, non-invasive contraceptive options that offer long-term efficacy without the need for daily or weekly administration. The segesterone acetate and ethinyl estradiol vaginal ring (Annovera) and other similar products are gaining traction, but the transdermal patch remains a popular choice due to its ease of use and minimal side effects[2].

Competitive Landscape

The competitive landscape includes a range of hormonal contraceptives, each with its own strengths and weaknesses. For instance, drospirenone combined with ethinyl estradiol is known for its desirable safety profile and additional benefits such as treating premenstrual dysphoric disorder. However, the norelgestromin and ethinyl estradiol patch stands out for its simplicity and user compliance[2][4].

Market Projections

Future Demand

The demand for convenient and effective contraceptive methods is expected to rise, driven by increasing awareness and the need for family planning. The norelgestromin and ethinyl estradiol transdermal patch is likely to remain a popular option due to its established safety and efficacy profile.

Technological Advancements

Future advancements in transdermal delivery systems could enhance the efficacy and safety of norelgestromin and ethinyl estradiol patches. For example, improvements in patch design and material could reduce skin irritation and improve adherence.

Regulatory Environment

Regulatory bodies continue to monitor the safety and efficacy of hormonal contraceptives. Any new findings or updates in clinical trials could influence regulatory approvals and market positioning. For instance, the FDA's approval of new estrogen components like estetrol has expanded options for women intolerant to ethinyl estradiol, which may impact market dynamics[2].

Key Considerations for Healthcare Providers

Patient Counseling

Healthcare providers should counsel patients on the proper use of the norelgestromin and ethinyl estradiol transdermal system, emphasizing the importance of applying the patch on the same day each week and avoiding skin areas that may have been used recently. Patients should also be informed about potential risks such as venous thromboembolism and the need for additional contraceptive methods during the initial week of use[4][5].

Contraindications and Warnings

Providers must be aware of the contraindications, including use in women over 35 years old who smoke, those with a BMI ≥ 30 kg/m², and those with certain medical conditions. They should also warn patients about the increased risk of thromboembolic events postpartum or after an abortion[4].

Key Takeaways

• Efficacy and Safety: Norelgestromin and ethinyl estradiol transdermal patches are effective in preventing pregnancy with a low Pearl Index, but they come with risks such as venous thromboembolism.
• Market Demand: The demand for non-oral, non-invasive contraceptives is rising, and this patch is likely to remain popular.
• Regulatory Environment: Ongoing regulatory monitoring and new approvals of alternative estrogen components could impact market dynamics.
• Patient Counseling: Proper use and awareness of potential risks are crucial for patient safety.

FAQs

Q: What is the primary mechanism of action of norelgestromin and ethinyl estradiol in preventing pregnancy?

A: The primary mechanism involves the inhibition of ovulation by suppressing gonadotropins, altering cervical mucus, and thinning the endometrium[3][5].

Q: What are the contraindications for using the norelgestromin and ethinyl estradiol transdermal patch?

A: Contraindications include use in women over 35 years old who smoke, those with a BMI ≥ 30 kg/m², and those with certain medical conditions such as a history of venous thromboembolism[4].

Q: How effective is the norelgestromin and ethinyl estradiol transdermal patch in preventing pregnancy?

A: The patch has a Pearl Index of 0.90, indicating a low rate of unwanted pregnancies, although it may be less effective in women weighing 90 kg or more[5].

Q: What are the potential side effects of using the norelgestromin and ethinyl estradiol transdermal patch?

A: Potential side effects include skin irritation, breakthrough bleeding, and an increased risk of venous thromboembolic events[4][5].

Q: Can the norelgestromin and ethinyl estradiol transdermal patch be used immediately after an abortion or miscarriage?

A: Yes, but with certain precautions. After a first-trimester abortion or miscarriage, the patch can be started immediately. However, after a second-trimester abortion or miscarriage, it should be started no earlier than 4 weeks later due to the increased risk of thromboembolic disease[4].

Sources

1. CenterWatch: Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for Up to 13 Cycles.
2. CCJM: Update on current contraceptive options: A case-based discussion.
3. MDPI: Effect of Norelgestromin and Ethinylestradiol in Transdermal Patches on the Clinical and Biochemical Parameters.
4. Drugs.com: Norelgestromin and Ethinyl Estradiol: Package Insert / Prescribing Info.
5. European Medicines Agency: Evra | European Medicines Agency (EMA).