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Ortho Tri-Cyclen LO
Ortho Tri-Cyclen LO is a Oral contraceptive (combined hormonal contraceptive) Small molecule drug developed by Bristol-Myers Squibb. It is currently FDA-approved for Contraception (pregnancy prevention), Acne vulgaris (FDA-approved indication).
Ortho Tri-Cyclen LO is an oral contraceptive that prevents pregnancy by suppressing ovulation through a combination of norgestimate and ethinyl estradiol.
Ortho Tri-Cyclen LO is an oral contraceptive that prevents pregnancy by suppressing ovulation through a combination of norgestimate and ethinyl estradiol. Used for Contraception (pregnancy prevention), Acne vulgaris (FDA-approved indication).
At a glance
| Generic name | Ortho Tri-Cyclen LO |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Oral contraceptive (combined hormonal contraceptive) |
| Target | Progesterone receptor, estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Gynecology |
| Phase | FDA-approved |
Mechanism of action
The drug combines a progestin (norgestimate) and an estrogen (ethinyl estradiol) to inhibit the luteinizing hormone (LH) surge required for ovulation. It also thickens cervical mucus to impede sperm penetration and alters the endometrium to prevent implantation. The 'LO' designation indicates a lower-dose formulation of ethinyl estradiol compared to standard Ortho Tri-Cyclen.
Approved indications
- Contraception (pregnancy prevention)
- Acne vulgaris (FDA-approved indication)
Common side effects
- Nausea
- Headache
- Breast tenderness
- Breakthrough bleeding
- Mood changes
- Venous thromboembolism
Key clinical trials
- To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada) (PHASE3)
- Acceptability of the NuvaRing Among Students (PHASE4)
- Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol (PHASE1)
- Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females (PHASE4)
- Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. (PHASE1)
- Drug Interaction - Oral Contraceptive (PHASE1)
- Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females (PHASE1)
- An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ortho Tri-Cyclen LO CI brief — competitive landscape report
- Ortho Tri-Cyclen LO updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Ortho Tri-Cyclen LO
What is Ortho Tri-Cyclen LO?
How does Ortho Tri-Cyclen LO work?
What is Ortho Tri-Cyclen LO used for?
Who makes Ortho Tri-Cyclen LO?
What drug class is Ortho Tri-Cyclen LO in?
What development phase is Ortho Tri-Cyclen LO in?
What are the side effects of Ortho Tri-Cyclen LO?
What does Ortho Tri-Cyclen LO target?
Related
- Drug class: All Oral contraceptive (combined hormonal contraceptive) drugs
- Target: All drugs targeting Progesterone receptor, estrogen receptor
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Contraception / Gynecology
- Indication: Drugs for Contraception (pregnancy prevention)
- Indication: Drugs for Acne vulgaris (FDA-approved indication)
- Compare: Ortho Tri-Cyclen LO vs similar drugs
- Pricing: Ortho Tri-Cyclen LO cost, discount & access