Drug InteractionsPhase 1NCT02159326
Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
A Phase 1 study testing Microgynon and Riociguat (Adempas,BAY63-2521) in people with Drug Interactions, run by Bayer at 1 site in Germany.
Trial summary
Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that… Read more about this study
- Who is it for?
- Ages 52 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions
- What is being tested?
- Microgynon and Riociguat (Adempas,BAY63-2521)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Jul 2015
- 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 52 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female subject
- Non-smokers of at least 3 month before screening
- Age: 52 to 65 years (inclusive) at the first screening examination
- Ethnicity: white
- Body mass index (BMI)>=20 and <=32 kg/m2
- Postmenopausal state, defined as
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- Medical history, if applicable (natural menopause at least 12 months before the first study drug administration and hormone analyses in serum
- Age<60 years: follicle-stimulating hormone (FSH) >40 IU/L in plasma
- Age <60 years: estradiol (E2) <20 ng/L (<73 pmol/L) in plasma
Who cannot join
- History of coronary artery disease, Symptomatic postural hypotension, History of bronchial asthma, known hypersensitivity to the study, relevant diseases within 4 weeks before study drug administration,
- Presence or a history of venous or arterial thrombotic / thromboembolic events or cerebrovascular accident, a high risk for venous or arterial thrombosis,
- Use of systemic or topical medicines or substances which oppose the study objectives, smoking, use of sex hormones in any forms
- Clinically relevant findings in the ECG, systolic blood pressure below 110 or above 145 mmHg, heart rate below 50 or above 95 beats per minute
- Clinically relevant findings in the gynecological examination,
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microgynon Riociguat Drug Interaction Study to Investigate the Effect of Riociguat 2.5 mg 3 Times Daily Multiple-dose Treatment on the Plasma Concentrations of / Exposure to Levonorgestrel and Ethinyl Estradiol in Healthy Postmenopausal Women in a 2-fold Crossover Design
Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that there is no interaction between Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered adequate to inform about safe use of Adempas with OCs.
- Conditions
- Drug Interactions
- Being tested
- Microgynon, Riociguat (Adempas,BAY63-2521)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrogynonDrug
single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
Riociguat (Adempas,BAY63-2521)Drug
multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) Receives: Drug: Microgynon |
| Arm2 | Experimental | multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment, a single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) Receives: Drug: Microgynon; Drug: Riociguat (Adempas,BAY63-2521) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)
Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)
Measured: Up to 4 months
Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)
Measured: Up to 4 months
Maximal concentration (Cmax) of Ethinylestradiol (EE)
Measured: Up to 4 months
Maximal concentration (Cmax) of Levonorgestrel (LNG)
Measured: Up to 4 months
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159326
- Sponsor's protocol ID
- 17309
- Other IDs
- 2014-000829-20, 2014
- Status last verified
- Aug 2015
- First submitted
- 6 Jun 2014
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microgynon Riociguat Drug Interaction Study to Investigate the Effect of Riociguat 2.5 mg 3 Times Daily Multiple-dose Treatment on the Plasma Concentrations of / Exposure to Levonorgestrel and Ethinyl Estradiol in Healthy Postmenopausal Women in a 2-fold Crossover Design
- ClinicalTrials.gov ID
- NCT02159326
- Acronym / sponsor ID
- 17309
- Conditions
- Drug Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 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.
Physicians might be concerned that Adempas may have a metabolic interaction with oral contraceptives (OC) that could decrease the contraceptive efficacy of the OC. The information regarding lack of potential pharmacokinetic interaction has been communicated; there is a need for more re-assurance and further data that there is no interaction between Adempas and OCs. A drug-drug interaction study of riociguat with an OC such as Microgynon in the least vulnerable population for these purposes, i.e. healthy postmenopausal women, is considered adequate to inform about safe use of Adempas with OCs.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: Microgynonsingle oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
| Arm2 | Experimental | Drug: Microgynon, Drug: Riociguat (Adempas,BAY63-2521)multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment, a single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) |
Who may qualify
- Ages
- 52 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy female subject
- Non-smokers of at least 3 month before screening
- Age: 52 to 65 years (inclusive) at the first screening examination
- Ethnicity: white
- Body mass index (BMI)>=20 and <=32 kg/m2
Key exclusion criteria (6 listed)
- History of coronary artery disease, Symptomatic postural hypotension, History of bronchial asthma, known hypersensitivity to the study, relevant diseases within 4 weeks before study drug administration,
- Presence or a history of venous or arterial thrombotic / thromboembolic events or cerebrovascular accident, a high risk for venous or arterial thrombosis,
- Use of systemic or topical medicines or substances which oppose the study objectives, smoking, use of sex hormones in any forms
- Clinically relevant findings in the ECG, systolic blood pressure below 110 or above 145 mmHg, heart rate below 50 or above 95 beats per minute
- Clinically relevant findings in the gynecological examination,
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 |
|---|---|---|
| Microgynonsingle oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted) | Drug | Arm1, Arm2 |
| Riociguat (Adempas,BAY63-2521)multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment | Drug | Arm2 |
Primary outcome
Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)
Time frame: Up to 4 months
Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)
Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)
Time frame: Up to 4 months
Maximal concentration (Cmax) of Ethinylestradiol (EE)
Time frame: Up to 4 months
Maximal concentration (Cmax) of Levonorgestrel (LNG)
Time frame: Up to 4 months
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 4 months
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 14 Aug 2015.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microgynon and Riociguat (Adempas,BAY63-2521) in people with Drug Interactions, run by Bayer at 1 site 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 9 inclusion and 6 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 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (AUC) of Ethinylestradiol (EE) (time frame: Up to 4 months). The study lists 4 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 14 Aug 2015.