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ethinyl estradiol/norelgestromin transdermal contraceptive
Ethinyl estradiol and norelgestromin suppress ovulation by inhibiting the luteinizing hormone surge and thickening cervical mucus, preventing pregnancy.
Ethinyl estradiol and norelgestromin suppress ovulation by inhibiting the luteinizing hormone surge and thickening cervical mucus, preventing pregnancy. Used for Prevention of pregnancy in women of childbearing age.
At a glance
| Generic name | ethinyl estradiol/norelgestromin transdermal contraceptive |
|---|---|
| Also known as | OrthoEvra |
| Sponsor | University of Pittsburgh |
| Drug class | Hormonal contraceptive |
| Target | Estrogen receptor and progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception |
| Phase | FDA-approved |
Mechanism of action
The combination of an estrogen (ethinyl estradiol) and a progestin (norelgestromin) works synergistically to prevent conception through multiple mechanisms: suppression of the hypothalamic-pituitary-ovarian axis to prevent ovulation, increased cervical mucus viscosity to impede sperm transport, and alterations to the endometrium. Delivered transdermally, the patch provides steady-state hormone levels with improved compliance compared to oral formulations.
Approved indications
- Prevention of pregnancy in women of childbearing age
Common side effects
- Breast tenderness
- Nausea
- Headache
- Application site reaction
- Breakthrough bleeding
- Venous thromboembolism
Key clinical trials
- Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users (PHASE2)
- Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles (PHASE3)
- Inpatient Adolescent Contraception (EARLY_PHASE1)
- Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women (PHASE2)
- Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis (PHASE4)
- A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control
- Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks
- Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.
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 |
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