Study 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

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

Trial summary

Enrollment Goal

Trial Dates

June 2014 - July 2015

Phase

Phase 1

Could I Receive a placebo

Products

Adempas (Riociguat, BAY63-2521)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
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)
Time Frame:
Up to 4 months
Safety Issue:
No
Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)
Time Frame:
Up to 4 months
Safety Issue:
No
Maximal concentration (Cmax) of Ethinylestradiol (EE)
Time Frame:
Up to 4 months
Safety Issue:
No
Maximal concentration (Cmax) of Levonorgestrel (LNG)
Time Frame:
Up to 4 months
Safety Issue:
No

Secondary Outcome

Number of participants with adverse events as a measure of safety and tolerability
Time Frame:
Up to 4 months
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

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.