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Transdermal system containing progestin
A transdermal progestin delivery system that releases the hormone through the skin to provide contraceptive and/or hormone replacement effects.
A transdermal progestin delivery system that releases the hormone through the skin to provide contraceptive and/or hormone replacement effects. Used for Contraception, Hormone replacement therapy (if applicable to specific formulation).
At a glance
| Generic name | Transdermal system containing progestin |
|---|---|
| Sponsor | Mylan Pharmaceuticals Inc |
| Drug class | Progestin contraceptive / Hormone replacement therapy |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Women's Health |
| Phase | Phase 3 |
Mechanism of action
Progestins work by suppressing the luteinizing hormone (LH) surge needed for ovulation, thickening cervical mucus to impede sperm transport, and altering the endometrium to prevent implantation. The transdermal formulation provides steady-state hormone delivery over several days, improving compliance and reducing fluctuations compared to oral dosing.
Approved indications
- Contraception
- Hormone replacement therapy (if applicable to specific formulation)
Common side effects
- Breast tenderness
- Headache
- Nausea
- Skin irritation at patch site
- Irregular bleeding
Key clinical trials
- Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential (PHASE3)
- Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches (PHASE1, PHASE2)
- 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
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |