ContraceptionPhase 1NCT02874248
E4/DRSP Single and Multiple Dose PK and Early QT Study
A Phase 1 study testing 15 mg E4/3 mg DRSP, 30 mg E4/6 mg DRSP and 60 mg E4/12 mg DRSP in people with Contraception, run by Estetra.
Trial summary
This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- 15 mg E4/3 mg DRSP, 30 mg E4/6 mg DRSP and 60 mg E4/12 mg DRSP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- May 2016to 21 Nov 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender : Healthy female subject
- Age : 18-50 years, inclusive
- Body mass index (BMI) : 18.0-35.0 kg/m2
- At screening, female subjects must be non-pregnant and non-lactating, or of non-childbearing potential
- Willing to use a double-barrier method of contraception from screening until 90 days after the follow up visit.
- Willingness to abstain from alcohol and grapefruit (juice) from 48 hours prior to admission into the clinical research center up to follow-up.
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- Normal resting supine blood pressure and pulse showing no clinically relevant deviations as judged by the PI at screening.
- Computerized (12-lead) ECG recording without signs of clinically relevant pathology at screening
- Willing and able to sign the ICF.
- Willing and able to comply with the study procedures
Who cannot join
- Postmenopausal status
- 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
- Condition of hyperkalemia resulting from renal insufficiency, hepatic dysfunction, adrenal insufficiency or medication intake
- Previous participation in the current study
- Use of:
- combined contraceptives (i.e., COC, Nuvaring®) within 28 days prior to the first dose administration until study completion
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- 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
- 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.
- Use of any tobacco products within the last 3 months prior to the first admission
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- Positive drug screening
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) 1 and 2 antibodies
- Participation in an investigational drug study within 60 days prior to the first drug administration in the current study
- History of relevant drug and/or food allergies
- 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
- Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, as judged by the PI
- History and/or family history of congenital long QT syndrome, unexplained syncope or other additional risks for Torsade de Pointes, or sudden death
- 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
- History of migraine with aura
- 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
- Contraindications for the use of contraceptive steroids
- Sponsor employees or clinical site personnel directly affiliated with this study
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel, Single Center Study to Investigate the Pharmacokinetics, Safety, Tolerability, and QT Concentration-effect Modelling of Estetrol in Combination With Drospirenone After Single and Multiple Dosing in Healthy Women
This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF).
Read the detailed description
This will be a randomized, double-blind, placebo-controlled, parallel, single center study in healthy female subjects. A total of 42 female subjects will be enrolled in 3 groups of 14 subjects each. A potential fourth group of 14 healthy female subjects may be added. In each group, subjects will be randomized in a 2.5 to 1 ratio between active (n=10) and placebo (n=4).
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
- Contraception
- Being tested
- 15 mg E4/3 mg DRSP, 30 mg E4/6 mg DRSP, 60 mg E4/12 mg DRSP, Visually matching placebo, 75 mg E4/15 mg DRSP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 mg E4/3 mg DRSPDrug
Also called 15 mg estetrol and 3 mg drospirenone
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 DRSPDrug
Also called 30 mg estetrol and 6 mg drospirenone
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 DRSPDrug
Also called 60 mg estetrol and 12 mg drospirenone
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 placeboDrug
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 DRSPDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 15 mg E4/3 mg DRSP (n=10) | Active comparator | 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 Receives: Drug: 15 mg E4/3 mg DRSP |
| Group1: Placebo (n=4) | Placebo comparator | 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 Receives: Drug: Visually matching placebo |
| Group 2: 30 mg E4/6 mg DRSP (n=10) | Active comparator | 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 Receives: Drug: 30 mg E4/6 mg DRSP |
| Group 2: Placebo (n=4) | Experimental | 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 Receives: Drug: Visually matching placebo |
| Group 3: 60 mg E4/12 mg DRSP (n=10) | Active comparator | 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 Receives: Drug: 60 mg E4/12 mg DRSP |
| Group 3: Placebo (n=4) | Placebo comparator | 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 Receives: Drug: Visually matching placebo |
| Group 4: 75 mg E4/15 mg DRSP (n=9) | Active comparator | 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 Receives: Drug: 75 mg E4/15 mg DRSP |
| Group 4: Placebo (n=4) | Placebo comparator | 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 Receives: Drug: Visually matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum observed plasma concentration of E4 and DSRP
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 and day 28 (steady state)
Tmax: time to attain maximum observed plasma concentration of E4 and DSRP
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 and day 28 (steady state)
AUC0-t: Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation (LLOQ) - for E4 and DSRP
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 and day 28 (steady state)
AUC0-24: area under the plasma concentration-time curve up to time 24 hours (where 24 hours is the dosing interval) using linear-log trapezoidal rule - for E4 and DSRP
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 only
AUC0-inf: Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Clast/kel, where Clast is the last measurable plasma concentration
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 only
Kel: terminal elimination rate constant of E4 and DSRP
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 and day 28 (steady state)
T1/2: terminal elimination half-life of E4 and DSRP, calculated as 0.693/kel
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 and day 28 (steady state)
AUC0-tau: Area under the plasma concentration time curve over a dosing interval tau - of E4 and DSRP
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 28 only
Ra: Accumulation ratio for AUC
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Measured: On day 1 and day 28 (steady state)
Secondary outcomes (3)
Number of adverse events and number of subjects with AEs as a measure of safety and tolerability
Any clinically significant observations in results of clinical laboratory tests, 12-lead ECGs, echocardiography, continuous cardiac monitoring (Holter monitoring), vital signs, or physical examinations will be recorded as AEs
Measured: From admission until follow-up visit (between day 37 and 41)
deltaQTcF as measured by Holter monitoring (continuous cardiac monitoring)
To define the effect of E4 in combination with DRSP on QT interval corrected with Fridericia's formula (QTcF)
Measured: Time matched on day -1 (for baseline measurements) and on day 28: 1 hour pre-dose until 24h post-dose
ECG parameters
To define the effect of E4 in combination with DRSP on heart rate (HR), PR, and QRS
Measured: Once during screening period; on day -2, 2, 15, 28, 29; once between day 2-3 and once between day 37 and 41 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion21 Nov 2016
- Study completion21 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estetra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeroen van de Wetering, MD, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874248
- Sponsor's protocol ID
- MIT-Es0001-C103
- Other IDs
- 2016-000861-22, 2016
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel, Single Center Study to Investigate the Pharmacokinetics, Safety, Tolerability, and QT Concentration-effect Modelling of Estetrol in Combination With Drospirenone After Single and Multiple Dosing in Healthy Women
- ClinicalTrials.gov ID
- NCT02874248
- Acronym / sponsor ID
- MIT-Es0001-C103
- Conditions
- Contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- EstetraIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- 21 Nov 2016 (actual)
- Study completion
- 21 Nov 2016 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to evaluate the effect of single and multiple therapeutic and supratherapeutic oral doses of E4/DRSP combinations on PK parameters, safety, tolerability and on cardiac repolarization, as detected by QT interval corrected with Fridericia's formula (QTcF).
Detailed description
This will be a randomized, double-blind, placebo-controlled, parallel, single center study in healthy female subjects. A total of 42 female subjects will be enrolled in 3 groups of 14 subjects each. A potential fourth group of 14 healthy female subjects may be added. In each group, subjects will be randomized in a 2.5 to 1 ratio between active (n=10) and placebo (n=4).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1: 15 mg E4/3 mg DRSP (n=10) | Active comparator | Drug: 15 mg E4/3 mg DRSPa 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) | Placebo comparator | Drug: Visually matching placeboa 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) | Active comparator | Drug: 30 mg E4/6 mg DRSPa 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) | Experimental | Drug: Visually matching placeboa 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) | Active comparator | Drug: 60 mg E4/12 mg DRSPa 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) | Placebo comparator | Drug: Visually matching placeboa 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) | Active comparator | Drug: 75 mg E4/15 mg DRSPa 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) | Placebo comparator | Drug: Visually matching placeboa 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Gender : Healthy female subject
- Age : 18-50 years, inclusive
- Body mass index (BMI) : 18.0-35.0 kg/m2
- At screening, female subjects must be non-pregnant and non-lactating, or of non-childbearing potential
- Willing to use a double-barrier method of contraception from screening until 90 days after the follow up visit.
Key exclusion criteria (25 listed)
- Postmenopausal status
- 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
- Condition of hyperkalemia resulting from renal insufficiency, hepatic dysfunction, adrenal insufficiency or medication intake
- Previous participation in the current study
- Use of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 mg E4/3 mg DRSPAlso: 15 mg estetrol and 3 mg drospirenonea 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 | Drug | Group 1: 15 mg E4/3 mg DRSP (n=10) |
| 30 mg E4/6 mg DRSPAlso: 30 mg estetrol and 6 mg drospirenonea 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 | Drug | Group 2: 30 mg E4/6 mg DRSP (n=10) |
| 60 mg E4/12 mg DRSPAlso: 60 mg estetrol and 12 mg drospirenonea 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 | Drug | Group 3: 60 mg E4/12 mg DRSP (n=10) |
| Visually matching placeboa 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 | Drug | Group 2: Placebo (n=4), Group 3: Placebo (n=4), Group 4: Placebo (n=4), Group1: Placebo (n=4) |
| 75 mg E4/15 mg DRSPa 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 | Drug | Group 4: 75 mg E4/15 mg DRSP (n=9) |
Primary outcome
Cmax: Maximum observed plasma concentration of E4 and DSRP
Time frame: On day 1 and day 28 (steady state)
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Tmax: time to attain maximum observed plasma concentration of E4 and DSRP
Time frame: On day 1 and day 28 (steady state)
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
AUC0-t: Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation (LLOQ) - for E4 and DSRP
Time frame: On day 1 and day 28 (steady state)
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
AUC0-24: area under the plasma concentration-time curve up to time 24 hours (where 24 hours is the dosing interval) using linear-log trapezoidal rule - for E4 and DSRP
Time frame: On day 1 only
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
AUC0-inf: Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Clast/kel, where Clast is the last measurable plasma concentration
Time frame: On day 1 only
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Kel: terminal elimination rate constant of E4 and DSRP
Time frame: On day 1 and day 28 (steady state)
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
T1/2: terminal elimination half-life of E4 and DSRP, calculated as 0.693/kel
Time frame: On day 1 and day 28 (steady state)
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
AUC0-tau: Area under the plasma concentration time curve over a dosing interval tau - of E4 and DSRP
Time frame: On day 28 only
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
Ra: Accumulation ratio for AUC
Time frame: On day 1 and day 28 (steady state)
PK sampling on day 1, 2-3, 4-8, 16-25, 26-27, 28, 29, 30, 31-35
3 secondary outcomes
Number of adverse events and number of subjects with AEs as a measure of safety and tolerability
Time frame: From admission until follow-up visit (between day 37 and 41)
deltaQTcF as measured by Holter monitoring (continuous cardiac monitoring)
Time frame: Time matched on day -1 (for baseline measurements) and on day 28: 1 hour pre-dose until 24h post-dose
ECG parameters
Time frame: Once during screening period; on day -2, 2, 15, 28, 29; once between day 2-3 and once between day 37 and 41 (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen van de Wetering, MD principal investigator
PRA Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 15 mg E4/3 mg DRSP, 30 mg E4/6 mg DRSP and 60 mg E4/12 mg DRSP in people with Contraception, run by Estetra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax: Maximum observed plasma concentration of E4 and DSRP (time frame: On day 1 and day 28 (steady state)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.