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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR ORTHO TRI-CYCLEN LO


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All Clinical Trials for Ortho Tri-cyclen Lo

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.
NCT00549666 ↗ A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects Completed Sunovion Phase 1 2007-08-01 A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ortho Tri-cyclen Lo

Condition Name

Condition Name for Ortho Tri-cyclen Lo
Intervention Trials
Healthy 5
Contraception 4
Pharmacokinetics 4
Drug Interactions 2
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Condition MeSH

Condition MeSH for Ortho Tri-cyclen Lo
Intervention Trials
Hepatitis C 3
Diabetes Mellitus 1
Metrorrhagia 1
Depressive Disorder, Major 1
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Clinical Trial Locations for Ortho Tri-cyclen Lo

Trials by Country

Trials by Country for Ortho Tri-cyclen Lo
Location Trials
United States 34
Canada 10
Netherlands 1
New Zealand 1
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Trials by US State

Trials by US State for Ortho Tri-cyclen Lo
Location Trials
Texas 6
Florida 3
Kansas 2
Wisconsin 2
Indiana 2
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Clinical Trial Progress for Ortho Tri-cyclen Lo

Clinical Trial Phase

Clinical Trial Phase for Ortho Tri-cyclen Lo
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Ortho Tri-cyclen Lo
Clinical Trial Phase Trials
Completed 17
Unknown status 2
Suspended 1
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Clinical Trial Sponsors for Ortho Tri-cyclen Lo

Sponsor Name

Sponsor Name for Ortho Tri-cyclen Lo
Sponsor Trials
Eli Lilly and Company 3
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 2
Bristol-Myers Squibb 2
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Sponsor Type

Sponsor Type for Ortho Tri-cyclen Lo
Sponsor Trials
Industry 22
Other 1
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Ortho Tri-Cyclen Lo: Clinical Trials, Market Analysis, and Projections

Introduction

Ortho Tri-Cyclen Lo is a low-dose oral contraceptive that combines the hormones norgestimate and ethinyl estradiol. It has been widely used for pregnancy prevention and is known for its efficacy and tolerability. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials

Efficacy and Safety

In an active controlled clinical trial, 1,673 subjects completed 11,003 cycles of Ortho Tri-Cyclen Lo use, resulting in a total of 20 reported pregnancies. This translates to an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use, indicating high effectiveness in preventing pregnancy[1][2].

Bleeding Patterns

The clinical trials also assessed the frequency and duration of unscheduled bleeding and/or spotting. It was found that 7–17% of women using Ortho Tri-Cyclen Lo experienced unscheduled bleeding per cycle in the first year, with the incidence decreasing over time. Only 0.2% of women discontinued the medication due to bleeding or spotting[4].

Side Effects and Tolerability

Ortho Tri-Cyclen Lo is noted for its low rates of nuisance side effects such as weight gain, acne, and facial hair growth, primarily due to the progestin norgestimate, which lowers serum free testosterone levels. This makes it a more tolerable option for many women[2].

Pharmacokinetics

Absorption and Metabolism

Norgestimate and ethinyl estradiol are rapidly absorbed following oral administration. Norgestimate is metabolized to its major active metabolite, norelgestromin, through first-pass mechanisms. Peak serum concentrations of norelgestromin and ethinyl estradiol are generally reached within 2 hours after dosing. The pharmacokinetics of these metabolites show dose proportionality and achieve steady-state conditions during the three-cycle study[1].

Elimination

The elimination half-life values for norelgestromin, norgestrel, and ethinyl estradiol at steady-state are 28.1 hours, 36.4 hours, and 17.7 hours, respectively. The metabolites are eliminated through renal and fecal pathways[1].

Market Analysis

Market Presence

Ortho Tri-Cyclen Lo has been a significant player in the U.S. contraceptive market since its FDA approval in 2002. It is developed by Ortho-McNeil Pharmaceutical, Inc., a leader in the U.S. contraceptive market. The drug had US sales of $488.4 million as of September 2015, highlighting its strong market presence[3][5].

Generic Competition

In 2016, Lupin Limited launched a generic equivalent of Ortho Tri-Cyclen Lo, known as Tri-Lo-Marzia™ Tablets, after receiving FDA approval. This generic version is AB-rated, meaning it is considered bioequivalent to the brand-name product. The introduction of generics has likely impacted the market share of the brand-name product but has also expanded access to this effective contraceptive[3][5].

Market Projections

Market Trends

The oral contraceptive market is expected to continue growing due to increasing awareness and demand for effective and convenient birth control methods. The low-dose formulation of Ortho Tri-Cyclen Lo, with its favorable side effect profile, is likely to remain a popular choice among women.

Competitive Landscape

The market for oral contraceptives is highly competitive, with numerous brand-name and generic options available. However, Ortho Tri-Cyclen Lo's established reputation and the trust built over years of use are expected to maintain its market position. The availability of generic versions will continue to influence pricing and market dynamics.

Future Outlook

Given the ongoing demand for reliable and tolerable birth control options, Ortho Tri-Cyclen Lo is expected to remain a significant player in the market. The drug's efficacy, combined with its aesthetic and discreet packaging options (such as the ORTHO PERSONAL PAK Tablet Dispensers), will continue to attract users[2].

Key Takeaways

  • High Efficacy: Ortho Tri-Cyclen Lo has a proven track record of preventing pregnancy with a low pregnancy rate.
  • Tolerability: The drug is known for its low incidence of side effects such as weight gain, acne, and facial hair growth.
  • Pharmacokinetics: Rapid absorption and metabolism with steady-state conditions achieved during the three-cycle study.
  • Market Presence: Strong market presence with significant sales figures, despite the introduction of generic competitors.
  • Future Outlook: Expected to remain a popular choice due to its efficacy and tolerability.

FAQs

Q: What are the active ingredients in Ortho Tri-Cyclen Lo?

A: The active ingredients are norgestimate and ethinyl estradiol.

Q: How effective is Ortho Tri-Cyclen Lo in preventing pregnancy?

A: It has a typical user efficacy pregnancy rate of 2.36 per 100 women-years of use.

Q: What are the common side effects associated with Ortho Tri-Cyclen Lo?

A: Common side effects include unscheduled bleeding, which tends to decrease over time. It is also known for low rates of weight gain, acne, and facial hair growth.

Q: Are there any generic versions of Ortho Tri-Cyclen Lo available?

A: Yes, generic versions such as Tri-Lo-Marzia™ Tablets are available and have been approved by the FDA.

Q: What are the contraindications for using Ortho Tri-Cyclen Lo?

A: Contraindications include a high risk of arterial or venous thrombotic diseases, liver tumors or liver disease, undiagnosed abnormal uterine bleeding, pregnancy, and breast cancer or other estrogen- or progestin-sensitive cancer[4].

Sources

  1. Ortho Tri-Cyclen Lo Tablets - accessdata.fda.gov
  2. Low-Dose Formulation of Ortho Tri-Cyclen(R) FDA Approved - Newswise
  3. Lupin Launches Generic Ortho Tri-Cyclen® Lo Tablets in the US - PR Newswire
  4. Ortho Tri-Cyclen Lo: Package Insert / Prescribing Info - Drugs.com
  5. Lupin Launches Generic Ortho Tri-Cyclen® Lo Tablets - FiercePharma

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