9 completed, 1 terminated, 1 withdrawn. 8 Phase 1, 2 Phase 4, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 7, Terminated 1 |
| Phase 4 | 2 | Completed 2 |
| Phase 3 | 1 | Withdrawn 1 |
Follow norgestimate: new trials by email Literature Review of norgestimate trials Research Report on norgestimate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Drug-drug Interaction Study to Investigate the Effect of Coadministration of EDP-305 on the PK of a Combined Oral Contraceptive in Healthy Female Subjects EDP-305, Oral Contraceptive - NASH - Nonalcoholic Steatohepatitis | Phase 1 | Completed | Enanta Pharmaceuticals, Inc | 43 | 2018-11-27 | 2019-07-24 |
| Hormone Replacement for Premature Ovarian Insufficiency Hormone Replacement Therapy, Combined Oral Contraceptives - Primary Ovarian Insufficiency | Phase 3 | Withdrawn | University of Pennsylvania | 2016-03-01 | 2019-07-05 | |
| Contraceptive Hormones and Women With Cystic Fibrosis Non-hormonal period, Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg - Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception | Phase 1 | Terminated | University of Pennsylvania | 5 | 2014-05-01 | 2016-01-08 |
| A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process), Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process) - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 101 | 2013-06-01 | 2014-10-03 |
| An Efficacy and Safety Study Comparing Oral Contraceptive Containing Norgestimate or Desogestrel for Acne Treatment Ethinyl estradiol/Norgestimate (EE/NGM), Ethinyl estradiol/Desogestrel (EE/DSG) - Acne Vulgaris | Phase 4 | Completed | Janssen-Cilag Ltd.,Thailand | 201 | 2008-12-01 | 2013-06-19 |
| Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol - Contraception | Phase 4 | Completed | Ortho-McNeil Janssen Scientific Affairs, LLC | 355 | 2008-05-01 | 2019-03-19 |
| Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females Ortho Tri-Cyclen (ethinyl estradiol + norgestimate), Ortho Tri-Cyclen LO (ethinyl estradiol + norgestimate) + Atazanavir/Ritonavir for 14 days then Ortho Tri-Cyclen for 7 days - HIV Infections | Phase 1 | Completed | Bristol-Myers Squibb | 22 | 2006-07-01 | 2011-04-08 |
| Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. Norgestimate/Ehinyl Estradiol; Folic acid. - Female Contraception, Contraception | Phase 1 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 53 | 2005-05-01 | 2011-06-08 |
| A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women. Norgestimate; Ethinyl Estradiol; Folic acid - Drug Interactions, Healthy | Phase 1 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 47 | 2005-05-01 | 2011-06-08 |
| Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women. Norgestimate; Ethinyl Estradiol; Folic acid. - Pharmacokinetics, Therapeutic Equivalency | Phase 1 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 54 | 2005-04-01 | 2011-06-08 |
| A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women. Norgestimate; Ethinyl Estradiol; Folic acid - Drug Interactions, Contraception | Phase 1 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 47 | 2005-01-01 | 2011-06-08 |
Acne Vulgaris (1) · HIV Infections (1) · Hemorrhage (1) · Non-alcoholic Fatty Liver Disease (1) · Primary Ovarian Insufficiency (1)
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (4) · University of Pennsylvania (2) · Bristol-Myers Squibb (1) · Enanta Pharmaceuticals, Inc (1) · Janssen Research & Development, LLC (1) · Janssen-Cilag Ltd.,Thailand (1) · Ortho-McNeil Janssen Scientific Affairs, LLC (1)
United States (4) · Netherlands (1) · Thailand (1)
2014 (1)