21 completed. 9 Phase 1, 8 Phase 2, 4 Phase 3, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 9 |
| Phase 2 | 8 | Completed 8 |
| Phase 3 | 4 | Completed 4 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow Estetrol: new trials by email Literature Review of Estetrol trials Research Report on Estetrol
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 |
|---|---|---|---|---|---|---|
| "Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition Estetrol 15 mg/Drospirenone 3 mg (24/4), Ethinylestradiol (EE) 20 mcg/Gestodene 75 mcg (21/7) - Ultrasound Finding: Ovulation Inhibition, Ovarian Activities, Cervical Mucus | Not applicable | Completed | Chulalongkorn University | 36 | 2024-05-01 | 2025-05-20 |
| Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women Estetrol, Placebo - Sexual Dysfunction, Physiological | Phase 2 | Completed | Estetra | 82 | 2024-01-29 | 2026-07-06 |
| The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation drospirenone/estetrol 3mg/14.2mg - Endometrial Polyp, Endometrial Diseases | Phase 4 | Completed | University of Palermo | 80 | 2023-01-01 | 2024-04-08 |
| Effect of Estetrol Monohydrate (E4) on QTc Interval Estetrol 20 mg, Estetrol 100 mg, Placebo - Prolonged QTc Interval | Phase 1 | Completed | Estetra | 32 | 2021-03-09 | 2023-09-15 |
| Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I) Estetrol, Placebo, Progesterone - Vasomotor Symptoms, Menopausal Symptoms | Phase 3 | Completed | Estetra | 1570 | 2019-12-30 | 2025-01-29 |
| Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort II) Estetrol oral tablet, Placebo oral tablet - Vasomotor Symptoms, Menopausal Symptoms | Phase 3 | Completed | Estetra | 1015 | 2019-09-27 | 2025-12-26 |
| Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers 30 mg estetrol (E4) - Food-effect | Phase 1 | Completed | Donesta Bioscience | 28 | 2019-01-30 | 2019-05-07 |
| Evaluation of Effects of Estetrol on Testosterone Suppression and Quality of Life in Prostate Cancer Patients Treated With an LHRH Agonist. Estetrol, Placebo Oral Tablet - Prostatic Neoplasm | Phase 2 | Completed | Pantarhei Oncology B.V. | 63 | 2018-04-16 | 2021-06-18 |
| Assessment of Safety and Efficacy of Estetrol in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast Cancer Estetrol - Breast Neoplasms | Phase 1 / Phase 2 | Completed | Pantarhei Oncology B.V. | 12 | 2017-06-01 | 2021-06-18 |
| Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers 5 mg E4 single-dose, 15 mg E4 single-dose, 45 mg E4 single-dose - Contraception, Menopause | Phase 1 | Completed | Estetra | 31 | 2017-01-31 | 2017-09-08 |
| "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG, 20 mcg EE/3 mg DRSP - Contraception, Liver Metabolism | Phase 1 / Phase 2 | Completed | Estetra | 101 | 2016-09-01 | 2018-02-05 |
| E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study 15 mg E4/3 mg DRSP - Contraception | Phase 3 | Completed | Estetra | 2148 | 2016-08-30 | 2020-02-10 |
| E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study 15 mg E4/3 mg DRSP - Contraception | Phase 3 | Completed | Estetra | 1577 | 2016-06-01 | 2019-10-04 |
| E4/DRSP Single and Multiple Dose PK and Early QT Study 15 mg E4/3 mg DRSP, 30 mg E4/6 mg DRSP, 60 mg E4/12 mg DRSP - Contraception | Phase 1 | Completed | Estetra | 55 | 2016-05-01 | 2017-04-21 |
| E4Relief (Response to Estetrol in Life Improvement for MEnopausal-associated Hot Flushes) Estetrol, Placebo - Hot Flushes | Phase 2 | Completed | Donesta Bioscience | 260 | 2016-05-01 | 2024-11-18 |
| Evaluation of Safety and Efficacy of Estetrol in Healthy Men estetrol, placebo - Prostatic Neoplasms | Phase 1 | Completed | Pantarhei Oncology B.V. | 45 | 2016-03-01 | 2017-02-09 |
| Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol Estetrol - Contraception, Menopause | Phase 1 | Completed | Estetra | 6 | 2016-02-01 | 2019-02-15 |
| Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2 estetrol, P 1 and placebo tablets, estetrol, P2 and placebo tablets, Estradiol valerate, dienogest and placebo tablets - Contraception | Phase 2 | Completed | Estetra | 396 | 2010-09-01 | 2012-09-14 |
| Feasibility Study Into the Contraceptive Effect of Estetrol estetrol, estetrol and desogestrel, estetrol and progesterone - Healthy | Phase 2 | Completed | Pantarhei Bioscience | 52 | 2007-11-01 | 2012-05-07 |
| Preoperative Estetrol in Breast Cancer placebo, Estetrol - Breast Cancer | Phase 2 | Completed | Pantarhei Bioscience | 30 | 2007-04-01 | 2012-07-02 |
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Hot Flashes (4) · Breast Neoplasms (2) · Prostatic Neoplasms (2) · Sexual Dysfunction, Physiological (1) · Uterine Diseases (1)
Estetra (11) · Pantarhei Bioscience (3) · Pantarhei Oncology B.V. (3) · Donesta Bioscience (2) · Chulalongkorn University (1) · University of Palermo (1)
Netherlands (5) · United States (5) · Canada (3) · Belgium (2) · Bulgaria (2) · Italy (2) · United Kingdom (2) · Argentina (1) · Austria (1) · Brazil (1) · Czechia (1) · Finland (1) · Germany (1) · Hungary (1) · Lithuania (1)
Christian F Singer, MD, MPH (1) · Christine Klipping (1) · Dan Apter, M.D. (1) · Dobrin Svinarov, MD (1) · Dobrin Sviranov, Prof (1) · Donesta Bioscience (1) · H. Coelingh Bennink, MD, PhD (1) · Herjan Coelingh Bennink, MD, PhD (1) · Jeroen van de Wetering, MD (1) · Litza McKenzie, MBChB (1) · Somsook Santibenchakul, Master (1) · Tjeert Mensinga, MD, PhD (1)
PMID 36809193, PMID 37023457, PMID 41289787, PMID 18464023, PMID 24932461, PMID 24997853, PMID 25961355, PMID 29931320, PMID 41388035, PMID 42068869
2016 (3), 2014 (1), 2015 (1), 2018 (1)