CLINICAL TRIALS PROFILE FOR ORTHO CYCLEN-21

All Clinical Trials for Ortho Cyclen-21

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00320567 ↗	The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 2	1969-12-31	The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with anorexia nervosa.
NCT00344383 ↗	An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Phase 2	2003-11-01	The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
NCT00439972 ↗	Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity	Unknown status	Ortho-McNeil Pharmaceutical	Phase 2	2007-02-01	The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.
NCT00439972 ↗	Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity	Unknown status	University of Washington	Phase 2	2007-02-01	The purpose of this study is to compare the effects of oral versus patch administration of hormonal contraception on hormone sensitive proteins such as lipoproteins, clotting factors and inflammatory proteins as well as blood sugar and insulin levels, antioxidant status and flow-mediated dilation of arm and forearm vessels. The hypothesis is that oral administration of contraceptive hormones will result in higher plasma levels of estrogen sensitive proteins originating from the liver while patch administration of contraceptive hormones will result in greater systemic effects of estrogen on vascular reactivity and antioxidant status.

Clinical Trial Conditions for Ortho Cyclen-21

Condition Name

Condition Name for Ortho Cyclen-21
Intervention	Trials
Healthy	5
Contraception	4
Pharmacokinetics	4
Drug Interactions	2

Condition MeSH

Condition MeSH for Ortho Cyclen-21
Intervention	Trials
Hepatitis C	3
HIV Infections	1
Anorexia Nervosa	1
Hepatitis, Chronic	1

Clinical Trial Locations for Ortho Cyclen-21

Trials by Country

Trials by Country for Ortho Cyclen-21
Location	Trials
United States	34
Canada	10
New Zealand	1
Netherlands	1

Trials by US State

Trials by US State for Ortho Cyclen-21
Location	Trials
Texas	6
Florida	3
Indiana	2
Arizona	2
California	2

Clinical Trial Progress for Ortho Cyclen-21

Clinical Trial Phase

Clinical Trial Phase for Ortho Cyclen-21
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Ortho Cyclen-21
Clinical Trial Phase	Trials
Completed	17
Unknown status	2
Suspended	1

Clinical Trial Sponsors for Ortho Cyclen-21

Sponsor Name

Sponsor Name for Ortho Cyclen-21
Sponsor	Trials
Eli Lilly and Company	3
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	2
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2

Sponsor Type

Sponsor Type for Ortho Cyclen-21
Sponsor	Trials
Industry	22
Other	1

Ortho Cyclen-21: Clinical Trials, Market Analysis, and Projections

Introduction

Ortho Cyclen-21, a combination oral contraceptive, is widely used for pregnancy prevention and the treatment of moderate acne vulgaris in females. This article delves into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Efficacy and Safety

Clinical trials for Ortho Cyclen-21 have demonstrated its efficacy in preventing pregnancy and treating acne. In studies involving 1,651 subjects who completed 24,272 cycles, the use-efficacy pregnancy rate was 0.96 per 100 women-years, indicating high effectiveness even with typical user errors[1].

For acne treatment, Ortho Tri-Cyclen (a variant of Ortho Cyclen with a different dosage regimen) showed significant reductions in inflammatory and total lesion counts in clinical trials. In two multicenter, placebo-controlled trials, Ortho Tri-Cyclen resulted in a mean percent reduction of 56.6% in inflammatory lesions and 49.6% in total lesions, compared to 36.6% and 30.3% for the placebo group, respectively[1].

Adverse Reactions

Common adverse reactions reported during clinical trials include headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues, mood disorders, flatulence, nervousness, and rash. These side effects are consistent with those associated with other oral contraceptives[5].

Market Analysis

Current Market Position

Ortho Cyclen-21 is a well-established product in the oral contraceptive market. Its dual indication for pregnancy prevention and acne treatment makes it a preferred choice for many women. The market for oral contraceptives is competitive, but Ortho Cyclen-21's proven efficacy and safety profile have maintained its market share.

Market Size and Growth

The global market for oral contraceptives is substantial and growing. While specific figures for Ortho Cyclen-21 are not readily available, the overall market for hormonal contraceptives is expected to continue growing due to increasing awareness and demand for reproductive health services.

Projections and Future Outlook

Market Trends

The oral contraceptive market is influenced by several trends, including increasing awareness of reproductive health, advancements in contraceptive technology, and changing regulatory environments. As more women seek effective and convenient birth control methods, the demand for products like Ortho Cyclen-21 is likely to remain strong.

Competitive Landscape

The competitive landscape for oral contraceptives is dynamic, with numerous brands and generic alternatives available. However, Ortho Cyclen-21's reputation and the trust built over years of use will continue to support its market position. Generic versions, such as Previfem, also contribute to the overall market share of similar formulations[2].

Regulatory Considerations

Regulatory requirements and guidelines play a crucial role in the pharmaceutical market. For Ortho Cyclen-21, adherence to FDA regulations and ongoing monitoring of safety and efficacy will be essential. Any changes in regulatory standards or new guidelines could impact the market dynamics[5].

User Experience and Satisfaction

User Reviews

User reviews and ratings for Ortho Cyclen-21 and its generic versions are generally positive. Many users report minimal side effects and high satisfaction with the medication's effectiveness. For example, a user on WebMD noted no significant side effects and expressed satisfaction with the medication's performance in shrinking ovarian cysts and preventing new ones[2].

Key Takeaways

• Efficacy: Ortho Cyclen-21 is highly effective in preventing pregnancy and treating moderate acne.
• Safety: Common adverse reactions include headache, abdominal pain, and mood disorders, which are typical for oral contraceptives.
• Market Position: The product maintains a strong market presence due to its dual indications and proven track record.
• Future Outlook: The market for oral contraceptives is expected to grow, driven by increasing awareness and demand for reproductive health services.
• User Satisfaction: Users generally report high satisfaction with minimal side effects.

FAQs

What are the primary indications for Ortho Cyclen-21?

Ortho Cyclen-21 is indicated for the prevention of pregnancy and the treatment of moderate acne vulgaris in females at least 15 years of age who have no known contraindications to oral contraceptive therapy and have achieved menarche[5].

What are the common side effects of Ortho Cyclen-21?

Common side effects include headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues, mood disorders, flatulence, nervousness, and rash[5].

How effective is Ortho Cyclen-21 in preventing pregnancy?

Clinical trials have shown that Ortho Cyclen-21 has a use-efficacy pregnancy rate of 0.96 per 100 women-years, indicating high effectiveness even with typical user errors[1].

Can Ortho Cyclen-21 be used for other conditions besides pregnancy prevention and acne treatment?

No, Ortho Cyclen-21 is specifically indicated for pregnancy prevention and the treatment of moderate acne vulgaris. It should not be used for other conditions without a healthcare provider's advice[5].

Are there any contraindications for using Ortho Cyclen-21?

Yes, contraindications include thrombophlebitis or thromboembolic disorders, past history of deep vein thrombophlebitis or thromboembolic disorders, liver disease, and other vascular problems[5].

Sources

1. Physicians' Package Insert Ortho Tri-Cyclen Tablets - FDA.
2. Ortho-Cyclen (21) Oral Reviews and User Ratings - WebMD.
3. Pediatric Clinical Trials Market Size to Hit USD 27.65 Billion by 2033 - BioSpace.
4. ORTHO TRI-CYCLEN Prescribing Information - Janssen.
5. Ortho Tri-Cyclen: Package Insert / Prescribing Information - Drugs.com.

Last updated: 2024-12-31