check_circleStudy Completed

Drug interactions

Bayer Identifier:

17309

ClinicalTrials.gov Identifier:

NCT02159326

EudraCT Number:

2014-000829-20

EU CT Number:

Not Available
Microgynon riociguat drug interaction study in healthy postmenopausal women

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

52 - 65 Years
  • - 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
    - 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
  • - 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 summary

Enrollment Goal
31
Trial Dates
June 2014 - July 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Mönchengladbach, 41061, Germany

Primary Outcome

  • Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)
    Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    No
  • Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    No
  • Maximal concentration (Cmax) of Ethinylestradiol (EE)
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    No
  • Maximal concentration (Cmax) of Levonorgestrel (LNG)
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 4 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.