Study Results
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Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2016-05-31
2016-11-21
Brief Summary
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Detailed Description
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Subjects will receive a single dose on Day 1 and, after a washout of at least 14 days, multiple doses on 14 consecutive days from Days 15 to 28.
Group 1 and Group 2 may be dosed in parallel. After completion of Group 1 and Group 2, a Dose Escalation Report (DER), including PK data up to at least 24 hours post-last dose, will be prepared by the Principal Investigator (PI). Escalation to the planned dose level of 60 mg E4/12 mg DRSP will only proceed if the safety and tolerability of the dose levels of 15 mg E4/3 mg DRSP and 30 mg E4/6 mg DRSP up to 24 hours post-last dose, are acceptable to the PI and the Sponsor and, if deemed necessary by the Independent Ethics Committee (IEC) following their review of the protocol, after a statement of no objection of the DER from the IEC.
After completion of Group 3, a second DER, including PK data, will be prepared by the PI. If in Group 3 the expected exposure level of approximately 4 times the exposure of Group 1 is not achieved, and treatment in Group 3 is well tolerated, an additional group with 14 subjects may be enrolled, using a dose level that is estimated to result in at least 4 times the exposure after administration of the 15 mg E4/3 mg DRSP therapeutic dose.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Group 1: 15 mg E4/3 mg DRSP (n=10)
a single oral dose of 15 mg E4/3 mg DRSP (n=10) followed, after a washout of at least 14 days, by multiple oral doses of 15 mg E4/3 mg DRSP (n=10) once daily for 14 days
15 mg E4/3 mg DRSP
a single oral dose of 15 mg E4/3 mg DRSP (n=10) followed, after a washout of at least 14 days, by multiple oral doses of 15 mg E4/3 mg DRSP (n=10) once daily for 14 days
Group1: Placebo (n=4)
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Visually matching placebo
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Group 2: 30 mg E4/6 mg DRSP (n=10)
a single oral dose of 30 mg E4/6 mg DRSP, followed, after a washout of at least 14 days, by multiple oral doses of 30 mg E4/6 mg DRSP once daily for 14 days
30 mg E4/6 mg DRSP
a single oral dose of 30 mg E4/6 mg DRSP, followed, after a washout of at least 14 days, by multiple oral doses of 30 mg E4/6 mg DRSP once daily for 14 days
Group 2: Placebo (n=4)
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Visually matching placebo
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Group 3: 60 mg E4/12 mg DRSP (n=10)
a single oral dose of 60 mg E4/12 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 60 mg E4/12 mg DRSP once daily for 14 days
60 mg E4/12 mg DRSP
a single oral dose of 60 mg E4/12 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 60 mg E4/12 mg DRSP once daily for 14 days
Group 3: Placebo (n=4)
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Visually matching placebo
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Group 4: 75 mg E4/15 mg DRSP (n=9)
a single oral dose of 75 mg E4/15 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 75 mg E4/15 mg DRSP once daily for 14 days
75 mg E4/15 mg DRSP
a single oral dose of 75 mg E4/15 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 75 mg E4/15 mg DRSP once daily for 14 days
Group 4: Placebo (n=4)
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Visually matching placebo
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
Interventions
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15 mg E4/3 mg DRSP
a single oral dose of 15 mg E4/3 mg DRSP (n=10) followed, after a washout of at least 14 days, by multiple oral doses of 15 mg E4/3 mg DRSP (n=10) once daily for 14 days
30 mg E4/6 mg DRSP
a single oral dose of 30 mg E4/6 mg DRSP, followed, after a washout of at least 14 days, by multiple oral doses of 30 mg E4/6 mg DRSP once daily for 14 days
60 mg E4/12 mg DRSP
a single oral dose of 60 mg E4/12 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 60 mg E4/12 mg DRSP once daily for 14 days
Visually matching placebo
a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
75 mg E4/15 mg DRSP
a single oral dose of 75 mg E4/15 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 75 mg E4/15 mg DRSP once daily for 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age : 18-50 years, inclusive
3. Body mass index (BMI) : 18.0-35.0 kg/m2
4. At screening, female subjects must be non-pregnant and non-lactating, or of non-childbearing potential
5. Willing to use a double-barrier method of contraception from screening until 90 days after the follow up visit.
6. Willingness to abstain from alcohol and grapefruit (juice) from 48 hours prior to admission into the clinical research center up to follow-up.
7. Normal resting supine blood pressure and pulse showing no clinically relevant deviations as judged by the PI at screening.
8. Computerized (12-lead) ECG recording without signs of clinically relevant pathology at screening
9. Willing and able to sign the ICF.
10. Willing and able to comply with the study procedures
Exclusion Criteria
2. History or presence of clinically relevant disease of any major system organ class (e.g., cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological, neurological, psychiatric or orthopedic disease) as judged by the PI
3. Condition of hyperkalemia resulting from renal insufficiency, hepatic dysfunction, adrenal insufficiency or medication intake
4. Previous participation in the current study
5. Use of:
* combined contraceptives (i.e., COC, Nuvaring®) within 28 days prior to the first dose administration until study completion
* progestogen-only contraceptive methods (e.g., minipill, implant, or hormonal intrauterine system) within 28 days prior to the first dose administration until study completion
* depot progestogen preparations or an injectable hormonal method of contraception (e.g., Depo-Provera®) within 6 months prior to the first dose until study completion
6. Use of:
* any prescription drugs or herbal supplements acting on CYP3A4 functions (e.g., St. John's Wort) within 28 days prior to the first study dose administration until study completion
* any over-the-counter medication or dietary supplements (vitamins included) within 14 days prior to the first study dose administration until study completion.
7. Use of any tobacco products within the last 3 months prior to the first admission
8. History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
9. Positive drug screening
10. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) 1 and 2 antibodies
11. Participation in an investigational drug study within 60 days prior to the first drug administration in the current study
12. History of relevant drug and/or food allergies
13. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.0 L of blood in the 10 months prior to the first drug administration in the current study
14. Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, as judged by the PI
15. History and/or family history of congenital long QT syndrome, unexplained syncope or other additional risks for Torsade de Pointes, or sudden death
16. History or presence of hormone-related malignancy treated or not, whatever the time of onset. History of malignancy of any other organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years prior to screening
17. History of migraine with aura
18. Any surgical or medical condition that could significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
19. Contraindications for the use of contraceptive steroids
20. Sponsor employees or clinical site personnel directly affiliated with this study
18 Years
50 Years
FEMALE
Yes
Sponsors
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Estetra
INDUSTRY
Responsible Party
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Principal Investigators
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Jeroen van de Wetering, MD
Role: PRINCIPAL_INVESTIGATOR
PRA Health Sciences
Other Identifiers
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2016-000861-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MIT-Es0001-C103
Identifier Type: -
Identifier Source: org_study_id
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