HealthyPhase 1NCT02175394
Effect of Multiple BI 1356 Doses of on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Female Premenopausal Subjects
A Phase 1 study testing Microgynon® and BI 1356 in people with Healthy, run by Boehringer Ingelheim.
Trial summary
The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the components of Microgynon® Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Microgynon® and BI 1356
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Oct 2008
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy premenopausal female subjects as determined by the results of screening based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), heart rate (HR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age 18 - 40 years
- BMI 18.5 - 27 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
- Gynaecological examination without relevant findings
Who cannot join
- Any finding of the medical examination deviating from normal and of clinical relevance. Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
Show all 26Show fewer
- Chronic or relevant acute infections
- History of relevant allergy or hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (greater than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to day 1 or during the trial
- Use of antibiotics and drugs known to inhibit or induce cytochrome P450 enzymes, especially CYP3A4, within one month prior to study day 1 or during the trial (CYP3A4 inhibitors are for example azole antimycotics, macrolides, CYP3A inducers are for example St. John's Wort or certain anticonvulsants)
- Participation in another trial with an investigational drug within two months prior to day 1 or during the trial
- Regular smokers of more than two cigarettes daily
- Drug or alcohol abuse (more than 20 g alcohol/day)
- Blood donation (more than 100 mL within four weeks prior to day 1)
- Excessive physical activities within 48 hours prior to day 1)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Positive pregnancy test, pregnancy or planning to become pregnant within 2 months of study completion, or lactation
- No use of an additional contraceptive method until 6 weeks after last study drug administration, i.e. barrier method, sexual abstinence, non-hormone-containing intrauterine device (IUD), surgical sterilisation (incl. hysterectomy) or vasectomized partner
- Use of oral contraceptive-containing intrauterine device, depot injection or contraceptive implants
- Existing or a history of confirmed venous thromboembolism (VTE), family history of idiopathic VTE and other known risk factors for VTE. Existing or previous arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation
- Relevant varicosis
- History of migraine
- History of liver disease, i.e. disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours
- Clinically relevant cycle anomalies and dysmenorrhoea within the last 12 months
- Usual menstrual cycle duration outside of a 26-32 days range
About this study
Official title: An Open, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 1356 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel
The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the components of Microgynon®
- Conditions
- Healthy
- Being tested
- Microgynon®, BI 1356
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microgynon®Drug
BI 1356Drug
| Study group | Role | What they receive |
|---|---|---|
| Microgynon® | Active comparator | Microgynon® once daily during period 1 (day 1 to day 14) Receives: Drug: Microgynon® |
| Microgynon® and BI 1356 | Experimental | Microgynon® combined with BI 1356, once daily during period 2 (day 15 to day 21) Receives: Drug: Microgynon®; Drug: BI 1356 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve of ethinylestradiol and levonogestrel (Microgynon®) in plasma over the dosing interval at steady-state (AUCτ,ss)
Measured: On day 14 and on day 21
Maximum measured concentration of ethinylestradiol and levonogestrel (Microgynon®) in plasma at steady state (Cmax,ss)
Measured: On day 14 and on day 21
Secondary outcomes (14)
Time from last dosing to the maximum measured concentration of EE and LNG in plasma at steady state (tmax,ss)
Measured: Up to day 22 after start of treatment
Apparent clearance of EE and LNG in plasma following extravascular administration at steady state (CL/F,ss)
Measured: Up to day 22 after start of treatment
Apparent volume of distribution of EE and LNG during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Measured: Up to day 22 after start of treatment
Terminal half-life of EE and LNG in plasma at steady state (t1/2,ss)
Measured: Up to day 22 after start of treatment
Terminal rate constant of EE and LNG in plasma at steady state (λz,ss)
Measured: Up to day 22 after start of treatment
Mean residence time of EE and LNG in the body at steady state after oral administration (MRTpo,ss)
Measured: Up to day 22 after start of treatment
Pre-dose plasma concentrations of EE and LNG for attainment of steady state
Measured: Up to day 21 after start of Microgynon® treatment
Pre-dose plasma concentration of BI 1356 for attainment of steady state
Measured: Day 15 up to 7 days after start of BI 1356 treatment (day 21)
Plasma concentration of BI 1356
Measured: Day 21
Number of patients with adverse events
Measured: Up to 14 weeks
Number of patients with clinically relevant changes in vital signs (BP, HR)
Measured: Up to 14 weeks
Number of patients with clinical relevant changes in laboratory evaluation (haematology, clinical chemistry and urinalysis)
Measured: Up to 14 weeks
Number of patients with clinically relevant changes in ECG recordings
Measured: Up to 14 weeks
Assessment of global tolerability by the investigator, a 4-point scale
Measured: Up to day 14 after last administration of study drug on day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJul 2008
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175394
- Sponsor's protocol ID
- 1218.44
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 1356 on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel
- ClinicalTrials.gov ID
- NCT02175394
- Acronym / sponsor ID
- 1218.44
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 26 Jun 2014 (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.
The objective was to investigate the effect of multiple oral doses of 5 mg BI 1356 on the steady-state pharmacokinetics of ethinylestradiol (EE) and levonorgestrel (LNG), the components of Microgynon®
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microgynon® | Active comparator | Drug: Microgynon®Microgynon® once daily during period 1 (day 1 to day 14) |
| Microgynon® and BI 1356 | Experimental | Drug: Microgynon®, Drug: BI 1356Microgynon® combined with BI 1356, once daily during period 2 (day 15 to day 21) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy premenopausal female subjects as determined by the results of screening based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), heart rate (HR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age 18 - 40 years
- BMI 18.5 - 27 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
- Gynaecological examination without relevant findings
Key exclusion criteria (26 listed)
- Any finding of the medical examination deviating from normal and of clinical relevance. Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
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 |
|---|---|---|
| Microgynon® | Drug | Microgynon®, Microgynon® and BI 1356 |
| BI 1356 | Drug | Microgynon® and BI 1356 |
Primary outcome
Area under the concentration-time curve of ethinylestradiol and levonogestrel (Microgynon®) in plasma over the dosing interval at steady-state (AUCτ,ss)
Time frame: On day 14 and on day 21
Maximum measured concentration of ethinylestradiol and levonogestrel (Microgynon®) in plasma at steady state (Cmax,ss)
Time frame: On day 14 and on day 21
14 secondary outcomes
Time from last dosing to the maximum measured concentration of EE and LNG in plasma at steady state (tmax,ss)
Time frame: Up to day 22 after start of treatment
Apparent clearance of EE and LNG in plasma following extravascular administration at steady state (CL/F,ss)
Time frame: Up to day 22 after start of treatment
Apparent volume of distribution of EE and LNG during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Time frame: Up to day 22 after start of treatment
Terminal half-life of EE and LNG in plasma at steady state (t1/2,ss)
Time frame: Up to day 22 after start of treatment
Terminal rate constant of EE and LNG in plasma at steady state (λz,ss)
Time frame: Up to day 22 after start of treatment
Mean residence time of EE and LNG in the body at steady state after oral administration (MRTpo,ss)
Time frame: Up to day 22 after start of treatment
Pre-dose plasma concentrations of EE and LNG for attainment of steady state
Time frame: Up to day 21 after start of Microgynon® treatment
Pre-dose plasma concentration of BI 1356 for attainment of steady state
Time frame: Day 15 up to 7 days after start of BI 1356 treatment (day 21)
Plasma concentration of BI 1356
Time frame: Day 21
Number of patients with adverse events
Time frame: Up to 14 weeks
Number of patients with clinically relevant changes in vital signs (BP, HR)
Time frame: Up to 14 weeks
Number of patients with clinical relevant changes in laboratory evaluation (haematology, clinical chemistry and urinalysis)
Time frame: Up to 14 weeks
Number of patients with clinically relevant changes in ECG recordings
Time frame: Up to 14 weeks
Assessment of global tolerability by the investigator, a 4-point scale
Time frame: Up to day 14 after last administration of study drug on day 21
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 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microgynon® and BI 1356 in people with Healthy, run by Boehringer Ingelheim.
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 5 inclusion and 26 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 8 Jul 2014. 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. 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?
Area under the concentration-time curve of ethinylestradiol and levonogestrel (Microgynon®) in plasma over the dosing interval at steady-state (AUCτ,ss) (time frame: On day 14 and on day 21). The study lists 2 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 8 Jul 2014.