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Last Updated: July 31, 2021

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CLINICAL TRIALS PROFILE FOR ESTETROL


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Clinical Trials for Estetrol

Trial ID Title Status Sponsor Phase Summary
NCT00163033 ↗ Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women Completed Pantarhei Bioscience Phase 1 Estetrol is a natural compound that is produced by the fetus during fetal life and circulates in the unborn child and the mother. It is an estrogenic compound. In this study the safety and tolerability of 28 days of the oral administration of estetrol in healthy postmenopausal women are investigated. In addition, the pharmacokinetics and some pharmacodynamic parameters are studied. The lowest dose of 2 mg estetrol is directly compared with 2 mg estradiol.
NCT00464516 ↗ Preoperative Estetrol in Breast Cancer Completed Pantarhei Bioscience Phase 2 The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer. Subjects will either receive estetrol or placebo during a 2 week treatment period. Several biological markers, such as a cellular growth marker and cell death markers, will be assessed in the tumor tissue and surrounding normal tissue before and after the treatment period. During the 2 week interval between diagnosis of breast cancer and surgical resection, no therapy for breast cancer is usually administered.
NCT00563472 ↗ Feasibility Study Into the Contraceptive Effect of Estetrol Completed Pantarhei Bioscience Phase 2 This is an open study in 50 young, healthy, female volunteers. Women who want to participate and who are using hormonal contraception stop using their hormonal contraceptive and wait for their first spontaneous menstruation (i.e. after a wash-out cycle). Women who do not use hormonal contraception wait for their next menstruation. From the 9th day after start of the menstruation onwards follicle growth will be monitored by ultrasonography until ovulation occurs or until day 24 after start of their menses. Women who ovulate within 24 days after start of their menses will be eligible to participate and will be stratified in one of 4 groups: 10 mg estetrol (E4) alone, 20 mg E4 alone, 20 mg E4 combined with 150 mcg desogestrel and 20 mg E4 combined with 200 mg progesterone. The subjects will be treated for 28 days. Treatment will start on the first day of their menses after the pre-treatment cycle. During the study period (28 days) the activity of the hypothalamic-pituitary-ovarian (HPO) axis will be investigated by measuring follicular development using ultrasonography and by determining serum concentrations of Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH), estradiol (E2) and Progesterone (P).
NCT01221831 ↗ Cycle Control Assessment of a Combined Oral Contraceptive Containing Estetrol and a Progestin P1 or P2 Completed Estetra Phase 2 This is an open-label, multi-centre, comparative study in young, healthy, female volunteers of reproductive age. Primary objective: - To investigate the effect of 2 dosages of estetrol combined with P1 or P2, on vaginal bleeding patterns (cycle control), in comparison with a combined oral contraceptive containing estradiol valerate and dienogest Secondary objectives: - To investigate ovulation inhibition - To investigate the effect on SHBG - To assess pregnancy rate - To evaluate subject satisfaction, dysmenorrhoea, acne, and body weight - To investigate return of menstruation after treatment - To evaluate general safety and acceptability
NCT02718144 ↗ Assessment of Safety and Efficacy of Estetrol in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast Cancer Not yet recruiting Pantarhei Oncology B.V. Phase 1/Phase 2 The current study is designed as an open-label, multi-center, seamless Phase I/II trial to assess the safety and efficacy of estetrol in postmenopausal patients with advanced estrogen receptor positive (ER+) breast cancer. The purpose of the Phase I part is to estimate the recommended Phase II dose. The Phase II part will be conducted to assess safety as well as antitumour activity of estetrol in postmenopausal patients with advanced breast cancer.
NCT02718378 ↗ Evaluation of Safety and Efficacy of Estetrol in Healthy Men Recruiting Pantarhei Oncology B.V. Phase 1 The current study is designed as a phase Ib multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral administration for 28 days.
NCT02720224 ↗ Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol Completed Quotient Clinical Phase 1 This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Estetrol

Condition Name

Condition Name for
Intervention Trials
Contraception 9
Healthy 2
Menopause 2
Vasomotor Symptoms 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Prostatic Neoplasms 2
Breast Neoplasms 2
Infection 1
Hot Flashes 1
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Clinical Trial Locations for Estetrol

Trials by Country

Trials by Country for
Location Trials
Netherlands 7
Belgium 3
United Kingdom 2
United States 2
Finland 2
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Trials by US State

Trials by US State for
Location Trials
Florida 1
Pennsylvania 1
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Clinical Trial Progress for Estetrol

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 5
Phase 2 8
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 9
Completed 8
Not yet recruiting 5
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Clinical Trial Sponsors for Estetrol

Sponsor Name

Sponsor Name for
Sponsor Trials
Estetra 14
Pantarhei Oncology B.V. 3
Pantarhei Bioscience 3
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 26
Other 4
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