23 completed, 2 unknown, 1 not yet recruiting, 1 terminated. 10 Phase 1, 8 Phase 4, 5 Phase 3, 2 Not applicable, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 10 |
| Phase 4 | 8 | Completed 6, Not yet recruiting 1, Unknown 1 |
| Phase 3 | 5 | Completed 5 |
| Not applicable | 2 | Completed 1, Terminated 1 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
Follow Norethindrone: new trials by email Literature Review of Norethindrone trials Research Report on Norethindrone
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 Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia Norethindrone 0.35 MG, Drospirenone - Hypertension, Preeclampsia | Phase 4 | Not yet recruiting | Oregon Health and Science University | 50 | 2026-07-01 | 2025-12-19 |
| A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants BMS-986196, Loestrin - Healthy Female Volunteers | Phase 1 | Completed | Bristol-Myers Squibb | 15 | 2023-06-06 | 2023-09-25 |
| Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive Evobruitnib, Combined oral contraceptive [ethinyl estradiol/ norethisterone (EE/NET)] - Healthy | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 20 | 2022-08-24 | 2025-11-14 |
| Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate Norethindrone Acetate 5 MG, Norethindrone 0.35 MG - Contraception | Phase 4 | Completed | Milton S. Hershey Medical Center | 6 | 2022-07-22 | 2024-07-16 |
| Progestin-Only Pill Use and Breastfeeding Study Progestin Only Contraceptive Pills - Contraception, Breastfeeding | Phase 4 | Completed | University of California, San Diego | 30 | 2021-10-25 | 2024-04-19 |
| Treatment of Prolonged Uterine Bleeding of Etonogestrel (ENG)-Releasing Implant Norethisterone 10mg/day, Placebo - Breakthrough Bleeding | Phase 4 | Completed | University of Sao Paulo | 114 | 2020-09-15 | 2024-09-23 |
| Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers Microgestin®, Levothyroxine, Glyburide - Healthy Volunteers | Phase 1 | Completed | Ironwood Pharmaceuticals, Inc. | 87 | 2019-03-11 | 2019-07-29 |
| Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam levonorgestrel/ Microlut, Norethindrone/ Noriday, Desogestrel/ Cerazette - Biological Availability | Phase 1 | Completed | Bayer | 68 | 2017-11-29 | 2020-04-15 |
| A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors Trametinib, Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol) - Solid Tumors | Phase 1 | Completed | Novartis Pharmaceuticals | 19 | 2016-10-20 | 2022-02-09 |
| A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone Ethinylestradiol, Norethindrone, JNJ-63623872 - Healthy | Phase 1 | Completed | Janssen Research & Development, LLC | 18 | 2015-12-01 | 2016-06-06 |
| Regulation of Cervical Mucus Secretion Leuprolide acetate, Estrogen and Progesterone Replacement, Progestin - Fertility, Contraception | Phase 4 | Completed | Oregon Health and Science University | 5 | 2015-03-29 | 2019-10-18 |
| Ovulation Incidence in Oral Contraceptive Users Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate, Norethindrone - Contraception, Ovulation | Phase 3 | Completed | University of Southern California | 58 | 2014-08-01 | 2025-12-26 |
| Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales Ethinyl Estradiol 35mcg/Norethindrone 1mg, Ethinyl Estradiol 20mcg/Norethindrone 1mg - Postpartum Depressive Mood, Postpartum Sexual Function | Phase 4 | Unknown | The Jones Institute | 33 | 2014-07-01 | 2014-08-07 |
| Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone isavuconazole, Oral Contraceptive (ethinyl estradiol / norethindrone) - Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone | Phase 1 | Completed | Astellas Pharma Global Development, Inc. | 24 | 2012-04-01 | 2012-07-16 |
| Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition estriol, Placebo, Norethindrone - Relapsing-remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis | Phase 2 | Unknown | University of California, Los Angeles | 64 | 2011-10-01 | 2019-11-06 |
| Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers NPC-01, IKH-01 - Healthy | Phase 3 | Completed | Nobelpharma | 14 | 2011-01-01 | 2025-03-06 |
| Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers NPC-01 - Healthy | Phase 3 | Completed | Nobelpharma | 12 | 2010-11-01 | 2025-06-17 |
| Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects ethinyl estradiol, norethindrone, VI-0521 - Healthy | Phase 1 | Completed | VIVUS LLC | 20 | 2009-01-01 | 2009-12-02 |
| Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions Norethindrone/Ethinyl Estradiol, FEMCON® Fe - Healthy | Phase 1 | Completed | Teva Pharmaceuticals USA | 36 | 2008-08-01 | 2011-05-30 |
| The Effect of the Mini-pill on Blood Factors in Women at Increased Risk for Forming Blood Clots Norethindrone - Women's Health, Blood Coagulation Disorders | Not applicable | Terminated | University of Vermont | 20 | 2007-12-01 | 2010-06-28 |
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Arthritis (1) · Blood Coagulation Disorders (1) · Breast Feeding (1) · Communicable Diseases (1) · Connective Tissue Diseases (1) · Dysmenorrhea (1) · Endometriosis (1) · Hypertension (1) · Immune System Diseases (1) · Lupus Erythematosus, Systemic (1) · Metrorrhagia (1) · Multiple Sclerosis (1) · Multiple Sclerosis, Chronic Progressive (1) · Multiple Sclerosis, Relapsing-Remitting (1) · Pelvic Pain (1)
Nobelpharma (3) · Oregon Health and Science University (2) · Teva Pharmaceuticals USA (2) · Astellas Pharma Global Development, Inc. (1) · Bayer (1) · Bristol-Myers Squibb (1) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (1) · Ironwood Pharmaceuticals, Inc. (1) · Janssen Research & Development, LLC (1) · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (1) · Milton S. Hershey Medical Center (1) · National Center for Research Resources (NCRR) (1) · Novartis Pharmaceuticals (1) · The Jones Institute (1) · University of California, Los Angeles (1)
United States (18) · Belgium (2) · Germany (2) · United Kingdom (2) · Brazil (1) · Netherlands (1) · Spain (1)
Takefumi Matuo, MD (2) · Brian T Nguyen, MD, MSc (1) · Carolina S Vieira, PhD, MD (1) · David S Guzick, M.D., Ph.D (1) · Fred M Howard, MD (1) · Graciela S. Alarcon (1) · Herman Ellman, MD (1) · Julia Tasset (1) · Julia V Johnson, MD (1) · Kristen P Wright, MD (1) · Leo Han, MD (1) · Mark Hornstein, MD (1) · Maurice Recanati (1)
PMID 15729953, PMID 17074351, PMID 19666684, PMID 22343553, PMID 29457758, PMID 31138184
2015 (1), 2017 (1)