Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Norgestimate; Ethinyl Estradiol; Folic acid · 2 trials · 5 indications
| Name | Type | Description |
|---|---|---|
| Norgestimate; Ethinyl Estradiol; Folic acid. | DRUG | - |
| Norgestimate; Ethinyl Estradiol; Folic acid | DRUG | - |
Inclusion Criteria: * Healthy * nonpregnant * nonlactating * nonsmoking women * weighing at least 110 pounds * With regular menstrual cycles * A body mass index between 16 and 29.9 kg/m2 * And a hematocrit of at least 36%. Exclusion Criteria: * History or presence of disorders commonly accepted a...
Norgestimate; ethinyl estradiol; folic acid is a combination oral contraceptive product that pairs two hormonal contraceptive agents, norgestimate and ethinyl estradiol, with a folic acid supplement. It is being developed by Johnson & Johnson (ticker JNJ) and is in Phase 1 clinical development for contraception.
Norgestimate; ethinyl estradiol; folic acid is being studied for contraception, specifically oral contraception. The combination is intended to prevent pregnancy through the hormonal components while also supplying folic acid. It is an investigational product in Phase 1 development and has not been approved for marketing.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of norgestimate; ethinyl estradiol; folic acid. The company is studying the combination product in Phase 1 clinical trials in healthy women.
Norgestimate; ethinyl estradiol; folic acid is in Phase 1 clinical development. It is an investigational combination product and is not FDA approved. The completed Phase 1 studies enrolled healthy women and evaluated pharmacokinetics, bioequivalence, and drug interactions.
Norgestimate; ethinyl estradiol; folic acid has been studied in two completed Phase 1 trials. NCT00709644 was a bioequivalence study of the oral contraceptive tablet with or without folic acid in 54 healthy women. NCT00709332 was a drug interaction study of folic acid and oral contraceptive tablets in 47 healthy women.