15 completed, 2 recruiting. 7 Phase 1, 5 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 7 |
| Phase 3 | 5 | Completed 5 |
| Phase 2 | 4 | Completed 4 |
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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 |
|---|---|---|---|---|---|---|
| International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS) Contraception | Recruiting | Center for Epidemiology and Health Research, Germany | 68100 | 2025-04-24 | 2025-08-20 | |
| 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 |
| International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study Contraception, Birth Control | Recruiting | Center for Epidemiology and Health Research, Germany | 101000 | 2023-06-28 | 2025-08-17 | |
| 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 |
| Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents E4/DRSP 15/3 mg combined tablet - Safety | Phase 3 | Completed | Estetra | 145 | 2020-12-28 | 2023-12-22 |
| 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 |
| Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study E4/DRSP, VAL - Contraception | Phase 1 | Completed | Estetra | 24 | 2018-04-12 | 2018-12-14 |
| E4/DRSP Ovarian Function Inhibition Study 15 mg E4/3 mg DRSP, 20 mcg EE/3 mg DRSP - Prevention of Pregnancy | Phase 2 | Completed | Estetra | 82 | 2017-02-07 | 2023-05-03 |
| 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 |
| 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 |
| Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers 15 mg E4/3 mg DRSP - Contraception | Phase 1 | Completed | Estetra | 28 | 2015-08-01 | 2016-08-02 |
| 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 |
Hot Flashes (2) · Sexual Dysfunction, Physiological (1)
Estetrol (11) · drospirenone (5) · Estradiol (1) · Ethinyl Estradiol (1) · Levonorgestrel (1) · Moxifloxacin (1) · P-2 (1) · Progesterone (1) · Valproic Acid (1) · dienogest (1) · drospirenone and ethinyl estradiol combination (1)
United States (5) · Canada (3) · United Kingdom (3) · Finland (2) · Germany (2) · Netherlands (2) · Poland (2) · Argentina (1) · Belgium (1) · Brazil (1) · Bulgaria (1) · Czechia (1) · Estonia (1) · Georgia (1) · Hungary (1)
Christine Klipping (2) · Klaas Heinemann, Dr. (2) · Dan Apter, M.D. (1) · Dobrin Sviranov, MD (1) · Dobrin Sviranov, Prof (1) · Jeroen van de Wetering, MD (1) · Litza McKenzie, MBChB (1) · Sharan Sidhu (1)
PMID 37023457, PMID 41289787, PMID 36809193, PMID 42068869
2016 (4), 2014 (1), 2015 (1), 2017 (1), 2019 (1)