Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

NCT ID: NCT02159326

Last Updated: 2015-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-07-31

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.

Conditions

Drug Interactions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Arm1

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

Group Type: EXPERIMENTAL

Microgynon

Intervention Type: DRUG

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

Arm2

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)

Group Type: EXPERIMENTAL

Microgynon

Intervention Type: DRUG

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

Riociguat (Adempas,BAY63-2521)

Intervention Type: DRUG

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

Interventions

Microgynon

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 52 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mönchengladbach, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2014-000829-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17309

Identifier Type: -

Identifier Source: org_study_id