Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02159326

Enrollment

Registered

2014-06-09

Start date

2014-06-30

Completion date

2015-07-31

Last updated

2015-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interactions

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.

Interventions

DRUGMicrogynon

single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)

DRUGRiociguat (Adempas,BAY63-2521)

multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

52 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)	Up to 4 months	Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)
Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)	Up to 4 months	—
Maximal concentration (Cmax) of Ethinylestradiol (EE)	Up to 4 months	—
Maximal concentration (Cmax) of Levonorgestrel (LNG)	Up to 4 months	—

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026