Biological AvailabilityPhase 1NCT03353857
Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam
A Phase 1 study testing levonorgestrel/ Microlut, Norethindrone/ Noriday and Desogestrel/ Cerazette in people with Biological Availability, run by Bayer at 2 sites in Germany.
Trial summary
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- levonorgestrel/ Microlut, Norethindrone/ Noriday and Desogestrel/ Cerazette
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesGermany
- Study dates
- 29 Nov 2017to 19 Feb 2019
- 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 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subject based on a complete medical history, physical examination, ECG, and clinical laboratory tests
- Age: 45 to 70 years (inclusive) at the first screening visit
- Minimum body weight 50 kg with Body mass index (BMI) above or equal to 18.5 kg/m², and below or equal to 30 kg/m² at the first screening visit
- Postmenopausal state, revealed indicated by either:
- medical history, if applicable (natural menopause at least 12 months prior to first study drug administration, for women younger than 60 years confirmed by follicle stimulating hormone (FSH) >40 IU/L AND estradiol ≤ 20 pg/mL; or
- surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration)
Who cannot join
- Relevant diseases within the last 4 weeks prior to the first study drug administration, i.e. any disease requiring treatment by a health-care provider
- Febrile illness within 1 week before the first study drug administration
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Presence or history of thrombosis, thrombophlebitis, thromboembolic diseases of veins and/or arteries, e.g. deep vein thrombosis, stroke, myocardial infarction, pulmonary embolism, transient ischemic attack, angina pectoris
- Presence or history of conditions that increase the risk of thromboembolic diseases, e.g. disturbances of the coagulation system, thromboembolic diseases in close relatives at age ≤50 years], valvular heart disease, atrial fibrillation, cardiac dysfunction)
- Presence, history, or suspected presence of malignant tumors or tumors of the liver and pituitary
Show all 15Show fewer
- Presence or history of liver disease e.g. disturbances of the bilirubin excretion (Dubin-Johnson and Rotor syndromes), cholecystectomy ; cholestasis, idiopathic icterus or pruritus during a previous pregnancy or estrogen-progestogen treatment
- Relevant kidney diseases or renal injury associated with multisystem diseases/disorders, e.g. glomerulonephritis systemic lupus erythematous, diabetic nephropathy. A history of a single episode of uncomplicated nephrolithiasis does not prevent participation
- Known metabolic disorder, e.g. diabetes mellitus, severe hypertriglyceridemia
- Migraine with neurologic symptoms
- Clinically significant depression, current or in the last year
- Known current thyroid disorders which require treatment. Subjects with an euthyroid struma who do not need any treatment can participate.
- Chronic respiratory insufficiency
- History of porphyria
- Contraindications for midazolam, e.g. myasthenia gravis, and sleep apnea
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
CRS Clinical-Research-Services Mönchengladbach GmbH
Mönchengladbach, North Rhine-Westphalia, 41061
About this study
Official title: Open-label, Randomized, Fixed Sequence Cross-over Study With Five Parallel Treatment Arms and Three Treatment Periods to Quantify the Drug-drug Interactions of Two Rifampicin Dose Strengths on Four Progestins and a Fixed Progestin-ethinylestradiol Combination Compared With Midazolam in Healthy Post-menopausal Women
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
- Conditions
- Biological Availability
- Being tested
- levonorgestrel/ Microlut, Norethindrone/ Noriday, Desogestrel/ Cerazette, Dienogest/ Visanne, Drospirenone, Ethinylestradiol/ Yasmin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levonorgestrel/ MicrolutDrug
In Period 1, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 1, In Period 2, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 15 In Period 3, 0.03 mg single dose administered as 1x0.03 mg tablet at Study Day 26
Norethindrone/ NoridayDrug
In Period 1, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 1, In Period 2, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 15 In Period 3, 0.35 mg single dose administered as 1x0.35 mg tablet at Study Day 26
Desogestrel/ CerazetteDrug
In Period 1, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 1, In Period 2, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 15 In Period 3, 0.075 mg single dose administered as 1x0.075 mg tablet at Study Day 26
Dienogest/ VisanneDrug
In Period 1, 2 mg single dose administered as 1x2 mg tablet on Study Day 1, In Period 2, 2 mg single dose administered as 1x2 mg tablet on Study Day 15 In Period 3, 2 mg single dose administered as 1x2 mg tablet at Study Day 26
Drospirenone, Ethinylestradiol/ YasminDrug
In Period 1, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 1, In Period 2, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 15, In Period 3, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 26,
Midazolam/ Midazolam-ratiopharmDrug
In Period 1, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 1, In Period 2, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 15 In Period 3, 1 mg single dose administered as 1x0.5 ml oral solution at Study Day 26
RifampicinDrug
In period 2, 10 mg (suspension, 0.5 ml) for 11 days at 10 mg/day In period 3, 600 mg (film-coated tablets) for 11 days at 600 mg/day
| Study group | Role | What they receive |
|---|---|---|
| levonorgestrel | Experimental | levonorgestrel and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. Receives: Drug: levonorgestrel/ Microlut; Drug: Midazolam/ Midazolam-ratiopharm; Drug: Rifampicin |
| norethindrone | Experimental | norethindrone and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. Receives: Drug: Norethindrone/ Noriday; Drug: Midazolam/ Midazolam-ratiopharm; Drug: Rifampicin |
| desogestrel | Experimental | desogestrel and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. Receives: Drug: Desogestrel/ Cerazette; Drug: Midazolam/ Midazolam-ratiopharm; Drug: Rifampicin |
| dienogest | Experimental | dienogest and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. Receives: Drug: Dienogest/ Visanne; Drug: Midazolam/ Midazolam-ratiopharm; Drug: Rifampicin |
| Drospirenone/ ethinylestradiol | Experimental | drospirenone/ethinylestradiol and midazolam will be administered on Day 1, Day 15 and Day 26.
rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. Receives: Drug: Drospirenone, Ethinylestradiol/ Yasmin; Drug: Midazolam/ Midazolam-ratiopharm; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time curve from zero to infinity (AUC) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of norethindrone in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of norethindrone in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of etonogestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of etonogestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of dienogest in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of dienogest in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of drospirenone (+EE) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of drospirenone (+EE) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of ethinylestradiol (+DRSP) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of ethinylestradiol (+DRSP) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of midazolam in combination with the hormonal contraceptive only (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of midazolam in combination with the hormonal contraceptive only (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Measured: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start29 Nov 2017
- Primary completion4 Jul 2018
- Study completion19 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353857
- Sponsor's protocol ID
- 19604
- Other IDs
- 2017-002792-26, 2017
- Status last verified
- Apr 2020
- First submitted
- 20 Nov 2017
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Randomized, Fixed Sequence Cross-over Study With Five Parallel Treatment Arms and Three Treatment Periods to Quantify the Drug-drug Interactions of Two Rifampicin Dose Strengths on Four Progestins and a Fixed Progestin-ethinylestradiol Combination Compared With Midazolam in Healthy Post-menopausal Women
- ClinicalTrials.gov ID
- NCT03353857
- Acronym / sponsor ID
- 19604
- Conditions
- Biological Availability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 19 Feb 2019 (actual)
- First posted
- 27 Nov 2017 (actual)
- 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.
Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| levonorgestrel | Experimental | Drug: levonorgestrel/ Microlut, Drug: Midazolam/ Midazolam-ratiopharm, Drug: Rifampicinlevonorgestrel and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| norethindrone | Experimental | Drug: Norethindrone/ Noriday, Drug: Midazolam/ Midazolam-ratiopharm, Drug: Rifampicinnorethindrone and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| desogestrel | Experimental | Drug: Desogestrel/ Cerazette, Drug: Midazolam/ Midazolam-ratiopharm, Drug: Rifampicindesogestrel and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| dienogest | Experimental | Drug: Dienogest/ Visanne, Drug: Midazolam/ Midazolam-ratiopharm, Drug: Rifampicindienogest and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
| Drospirenone/ ethinylestradiol | Experimental | Drug: Drospirenone, Ethinylestradiol/ Yasmin, Drug: Midazolam/ Midazolam-ratiopharm, Drug: Rifampicindrospirenone/ethinylestradiol and midazolam will be administered on Day 1, Day 15 and Day 26. rifampicin (10 mg/day) will be administered on Day 8 to Day 18 and rifampicin (600 mg/day) on Day 19 to Day 29. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy female subject based on a complete medical history, physical examination, ECG, and clinical laboratory tests
- Age: 45 to 70 years (inclusive) at the first screening visit
- Minimum body weight 50 kg with Body mass index (BMI) above or equal to 18.5 kg/m², and below or equal to 30 kg/m² at the first screening visit
- Postmenopausal state, revealed indicated by either:
Key exclusion criteria (15 listed)
- Relevant diseases within the last 4 weeks prior to the first study drug administration, i.e. any disease requiring treatment by a health-care provider
- Febrile illness within 1 week before the first study drug administration
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Presence or history of thrombosis, thrombophlebitis, thromboembolic diseases of veins and/or arteries, e.g. deep vein thrombosis, stroke, myocardial infarction, pulmonary embolism, transient ischemic attack, angina pectoris
- Presence or history of conditions that increase the risk of thromboembolic diseases, e.g. disturbances of the coagulation system, thromboembolic diseases in close relatives at age ≤50 years], valvular heart disease, atrial fibrillation, cardiac dysfunction)
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 |
|---|---|---|
| levonorgestrel/ MicrolutIn Period 1, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 1, In Period 2, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 15 In Period 3, 0.03 mg single dose administered as 1x0.03 mg tablet at Study Day 26 | Drug | levonorgestrel |
| Norethindrone/ NoridayIn Period 1, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 1, In Period 2, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 15 In Period 3, 0.35 mg single dose administered as 1x0.35 mg tablet at Study Day 26 | Drug | norethindrone |
| Desogestrel/ CerazetteIn Period 1, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 1, In Period 2, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 15 In Period 3, 0.075 mg single dose administered as 1x0.075 mg tablet at Study Day 26 | Drug | desogestrel |
| Dienogest/ VisanneIn Period 1, 2 mg single dose administered as 1x2 mg tablet on Study Day 1, In Period 2, 2 mg single dose administered as 1x2 mg tablet on Study Day 15 In Period 3, 2 mg single dose administered as 1x2 mg tablet at Study Day 26 | Drug | dienogest |
| Drospirenone, Ethinylestradiol/ YasminIn Period 1, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 1, In Period 2, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 15, In Period 3, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 26, | Drug | Drospirenone/ ethinylestradiol |
| Midazolam/ Midazolam-ratiopharmIn Period 1, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 1, In Period 2, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 15 In Period 3, 1 mg single dose administered as 1x0.5 ml oral solution at Study Day 26 | Drug | Drospirenone/ ethinylestradiol, desogestrel, dienogest, levonorgestrel, norethindrone |
| RifampicinIn period 2, 10 mg (suspension, 0.5 ml) for 11 days at 10 mg/day In period 3, 600 mg (film-coated tablets) for 11 days at 600 mg/day | Drug | Drospirenone/ ethinylestradiol, desogestrel, dienogest, levonorgestrel, norethindrone |
Primary outcome
Area under the plasma concentration time curve from zero to infinity (AUC) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of norethindrone in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of norethindrone in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of etonogestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of etonogestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of dienogest in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of dienogest in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of drospirenone (+EE) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of drospirenone (+EE) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of ethinylestradiol (+DRSP) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of ethinylestradiol (+DRSP) in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Area under the plasma concentration time curve from zero to infinity (AUC) of midazolam in combination with the hormonal contraceptive only (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
Maximum plasma concentration (Cmax) of midazolam in combination with the hormonal contraceptive only (without RIF) and in combination with 10 mg/d and 600 mg/d RIF
Time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3
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 15 Apr 2020.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing levonorgestrel/ Microlut, Norethindrone/ Noriday and Desogestrel/ Cerazette in people with Biological Availability, run by Bayer at 2 sites in Germany.
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 6 inclusion and 15 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 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 plasma concentration time curve from zero to infinity (AUC) of levonorgestrel in the presence of MDZ (without RIF) and in combination with 10 mg/d and 600 mg/d RIF (time frame: Over 7 days in Period 1 (no RIF) and 4 days in treatment Periods 2 and 3). The study lists 14 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 15 Apr 2020.