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Ortho Tri Cyclen
Ortho Tri Cyclen is a Oral contraceptive (combined hormonal contraceptive) Small molecule drug developed by Virginia Commonwealth University. It is currently FDA-approved for Contraception (pregnancy prevention), Acne vulgaris (FDA-approved indication).
Ortho Tri-Cyclen is an oral contraceptive that prevents pregnancy by suppressing ovulation through a combination of norgestimate and ethinyl estradiol.
Ortho Tri-Cyclen 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 |
|---|---|
| Sponsor | Virginia Commonwealth University |
| 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. Additionally, it thickens cervical mucus to impede sperm penetration and alters the endometrium to prevent implantation. The triphasic formulation varies hormone doses across the cycle to mimic natural hormonal patterns while maintaining contraceptive efficacy.
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)
- Elagolix for Fertility Enhancement Clinical Trial (PHASE2)
- Inpatient Adolescent Contraception (EARLY_PHASE1)
- A Study to Evaluate Effects of CC-99677 on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Participants (PHASE1)
- 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)
- Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects (PHASE1)
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 CI brief — competitive landscape report
- Ortho Tri Cyclen updates RSS · CI watch RSS
- Virginia Commonwealth University portfolio CI
Frequently asked questions about Ortho Tri Cyclen
What is Ortho Tri Cyclen?
How does Ortho Tri Cyclen work?
What is Ortho Tri Cyclen used for?
Who makes Ortho Tri Cyclen?
What drug class is Ortho Tri Cyclen in?
What development phase is Ortho Tri Cyclen in?
What are the side effects of Ortho Tri Cyclen?
What does Ortho Tri Cyclen target?
Related
- Drug class: All Oral contraceptive (combined hormonal contraceptive) drugs
- Target: All drugs targeting Progesterone receptor, estrogen receptor
- Manufacturer: Virginia Commonwealth University — full pipeline
- Therapeutic area: All drugs in Contraception / Gynecology
- Indication: Drugs for Contraception (pregnancy prevention)
- Indication: Drugs for Acne vulgaris (FDA-approved indication)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing