Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

Drug Interactions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02159326
• Other study ID #: 17309
• Secondary ID: 2014-000829-20
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2014
• Last updated: August 13, 2015
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 52 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Drug Interactions

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)	Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)	Up to 4 months	No
Primary	Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)		Up to 4 months	No
Primary	Maximal concentration (Cmax) of Ethinylestradiol (EE)		Up to 4 months	No
Primary	Maximal concentration (Cmax) of Levonorgestrel (LNG)		Up to 4 months	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 4 months	Yes

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