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norelgestromin/ethinyl estradiol contraceptive system · 4 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| norelgestromin + ethinyl estradiol | DRUG | - |
| norelgestromin + ethinyl estradiol; mercilon | DRUG | - |
| norelgestromin + ethinyl estradiol; triphasil. | DRUG | - |
| norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system. | DRUG | - |
Inclusion Criteria: * Healthy women with regular menstrual cycles * sexually active and at risk of pregnancy * nonpregnant * acceptable body mass index (BMI) * last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since * sitting BP\<140mmHg/\<90mmHg * 1 normal men...
It is used for female contraception. The transdermal system delivers norelgestromin and ethinyl estradiol through the skin to prevent pregnancy. It is being developed by Johnson & Johnson and is in Phase 3 clinical development.
Norelgestromin/ethinyl estradiol contraceptive system works by targeting the progesterone receptor (PGR) as an agonist. Norelgestromin is a progestin that binds to and activates the progesterone receptor, while ethinyl estradiol is an estrogen. Together they act on the endocrine system to prevent ovulation and thicken cervical mucus.
Johnson & Johnson (ticker: JNJ) is developing the norelgestromin/ethinyl estradiol contraceptive system. The company is responsible for the clinical development of this transdermal contraceptive.
Norelgestromin/ethinyl estradiol contraceptive system is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trials have been completed.
The norelgestromin/ethinyl estradiol contraceptive system has been studied in three completed Phase 3 trials: NCT00236795, NCT00236782, and NCT00236769, which enrolled 1,494, 1,517, and 1,751 participants respectively. A Phase 1 bioequivalence study, NCT00775086, enrolled 42 participants. All trials are completed.
Norelgestromin/ethinyl estradiol contraceptive system is also known as norelgestromin/ethinyl estradiol (NGMN/EE) transdermal contraceptive system. It has been referred to in study titles alongside Mercilon and Triphasil, which are comparator contraceptives used in clinical trials, but they are distinct products.