Clinical trial NCT02159326: Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interactions
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 31
Sex: FEMALE
Minimum age (years): 52
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)
timeFrame: Up to 4 months
measure: Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)
timeFrame: Up to 4 months
measure: Maximal concentration (Cmax) of Ethinylestradiol (EE)
timeFrame: Up to 4 months
measure: Maximal concentration (Cmax) of Levonorgestrel (LNG)
timeFrame: Up to 4 months
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: