Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

NCT02159326 | Completed Phase 1

• 2 other identifiers: 173092014-000829-20
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)

  Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)

  Up to 4 months

• 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 Outcomes (1)

• Number of participants with adverse events as a measure of safety and tolerability

  Up to 4 months

Study Arms (2)

Arm1

EXPERIMENTAL

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

Drug: Microgynon

Arm2

EXPERIMENTAL

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)

Drug: Microgynon; Drug: Riociguat (Adempas,BAY63-2521)

Interventions

Microgynon DRUG

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

Arm1; Arm2

Riociguat (Adempas,BAY63-2521) DRUG

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

Arm2

Eligibility Criteria

• Age: 52 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

MeSH Terms

Interventions

ethinyl estradiol, levonorgestrel drug combination; riociguat

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 9, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

DE (1)