19 completed, 1 terminated, 1 unknown. 13 Phase 3, 3 Phase 2, 2 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 13 |
| Phase 2 | 3 | Completed 2, Unknown 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 1, Terminated 1 |
Follow estradiol, norethindrone drug combination: new trials by email Literature Review of estradiol, norethindrone drug combination trials Research Report on estradiol, norethindrone drug combination
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 |
|---|---|---|---|---|---|---|
| PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic. Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040) - Contraceptive | Completed | Bayer | 296 | 2019-08-26 | 2022-12-21 | |
| Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Estradiol/norethindrone acetate, Placebo for relugolix - Uterine Leiomyoma, Uterine Fibroids | Phase 3 | Completed | Myovant Sciences GmbH | 229 | 2018-10-16 | 2024-06-25 |
| SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain Relugolix, Estradiol/norethindrone acetate - Endometriosis | Phase 3 | Completed | Myovant Sciences GmbH | 802 | 2018-05-22 | 2023-08-08 |
| SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo - Endometriosis Related Pain | Phase 3 | Completed | Myovant Sciences GmbH | 638 | 2017-12-07 | 2021-06-28 |
| SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo - Endometriosis Related Pain | Phase 3 | Completed | Myovant Sciences GmbH | 623 | 2017-11-01 | 2021-06-28 |
| LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Estradiol/norethindrone acetate - Heavy Menstrual Bleeding, Uterine Fibroid | Phase 3 | Completed | Myovant Sciences GmbH | 477 | 2017-10-19 | 2024-05-09 |
| A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain Estradiol/Norethindrone Acetate, Placebo for Elagolix, Elagolix - Endometriosis | Phase 3 | Completed | AbbVie | 681 | 2017-07-07 | 2024-12-20 |
| LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Estradiol/norethindrone acetate, Relugolix placebo - Heavy Menstrual Bleeding, Uterine Fibroid | Phase 3 | Completed | Myovant Sciences GmbH | 382 | 2017-06-14 | 2022-04-20 |
| LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Relugolix, Estradiol/norethindrone acetate, Estradiol/norethindrone acetate placebo - Heavy Menstrual Bleeding, Uterine Fibroid | Phase 3 | Completed | Myovant Sciences GmbH | 388 | 2017-04-26 | 2022-04-19 |
| An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Estradiol/Norethindrone Acetate, Elagolix - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | AbbVie | 433 | 2016-09-14 | 2021-07-13 |
| Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study) Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | AbbVie | 378 | 2016-02-03 | 2021-07-13 |
| Estrogen Diastolic Heart Failure Estradiol/Norethindrone acetate, Placebo - Menopause | Phase 4 | Terminated | Gretchen Wells | 4 | 2016-02-01 | 2018-08-08 |
| Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate - Uterine Fibroids, Heavy Menstrual Bleeding | Phase 3 | Completed | AbbVie | 413 | 2015-12-22 | 2020-06-29 |
| Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) Elagolix placebo, Elagolix, 0.5 mg estradiol / 0.1 mg norethindrone acetate - Heavy Uterine Bleeding, Uterine Fibroids | Phase 2 | Completed | AbbVie | 571 | 2013-04-08 | 2020-07-21 |
| Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Elagolix, Placebo, Estradiol/Norethindrone acetate (E2/NETA) - Heavy Uterine Bleeding, Uterine Fibroids | Phase 2 | Completed | AbbVie (prior sponsor, Abbott) | 271 | 2011-09-08 | 2021-07-13 |
| Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen progesterone, activella - Endometrial Hyperplasia, Endometrial Cancer | Phase 2 | Unknown | Rabin Medical Center | 60 | 2009-06-01 | 2009-06-12 |
| Endometrial Safety Study 0.25mg DRSP / 0.5mg E2 (BAY86-4891), 0.5mg NETA / 1.0mg E2 (Activella) - Postmenopause | Phase 3 | Completed | Bayer | 662 | 2007-08-01 | 2014-12-31 |
| Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions Estradiol/Norethindrone acetate, Activella® - Healthy | Phase 1 | Completed | Teva Pharmaceuticals USA | 36 | 2007-02-01 | 2010-12-17 |
| Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions Estradiol/Norethindrone acetate, Activella® - Healthy | Phase 1 | Completed | Teva Pharmaceuticals USA | 40 | 2007-01-01 | 2010-12-08 |
| Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089) tibolone, estradiol-norethisterone - Sexual Dysfunction | Phase 3 | Completed | Organon and Co | 358 | 2004-03-23 | 2022-02-04 |
Showing 20 of 21. Sign in to see all of them.
Leiomyoma (9) · Menorrhagia (9) · Dysmenorrhea (4) · Endometriosis (4) · Pain (3) · Dyspareunia (1) · Endometrial Hyperplasia (1) · Endometrial Neoplasms (1) · Hot Flashes (1) · Hypertension (1) · Hyperuricemia (1) · Myofibroma (1) · Pelvic Pain (1) · Sexual Dysfunction, Physiological (1)
Myovant Sciences GmbH (7) · AbbVie (5) · Bayer (2) · Teva Pharmaceuticals USA (2) · AbbVie (prior sponsor, Abbott) (1) · Anna Posadzy-Małaczyńska (1) · Gretchen Wells (1) · Organon and Co (1) · Rabin Medical Center (1)
United States (13) · Canada (8) · Brazil (7) · Poland (7) · Czechia (6) · Italy (6) · South Africa (6) · Chile (5) · Hungary (5) · Belgium (4) · Argentina (3) · Puerto Rico (3) · Australia (2) · Bulgaria (2) · Finland (2)
Paul Y Tam, M.D., F.R.C.P., F.A.C.P. (2) · Boris Kaplan, prof (1) · Charlotte Owens, MD (1) · Gretchen L Wells, MD, PhD (1)
PMID 34878624, PMID 36357960, PMID 37477173, PMID 37863160, PMID 31971678, PMID 33596357, PMID 33650259, PMID 34553161, PMID 34582715, PMID 35415708, PMID 35675604, PMID 35717987, PMID 37183454, PMID 37283994, PMID 37982388, PMID 39381651, PMID 39466126, PMID 18304284, PMID 23531117, PMID 27733082, PMID 30303923, PMID 31033362, PMID 31069056, PMID 32702363, PMID 34435897, PMID 37666383, PMID 38243752, PMID 38906210, PMID 40320117
2017 (4), 2016 (2), 2018 (1)