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Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT02159326
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drug Interactions Drug: Microgynon Drug: Riociguat (Adempas,BAY63-2521) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Riociguat

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm1
single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
 Drug: Microgynon
single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
Experimental: 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)
 Drug: Microgynon
single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)

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


Outcome Measures
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Primary Outcome Measures :
  1. Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE) [ Time Frame: Up to 4 months ]
    Plasma concentrations Ethinyl estradiol (EE) and levonorgestrel (LNG)

  2. Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG) [ Time Frame: Up to 4 months ]
  3. Maximal concentration (Cmax) of Ethinylestradiol (EE) [ Time Frame: Up to 4 months ]
  4. Maximal concentration (Cmax) of Levonorgestrel (LNG) [ Time Frame: Up to 4 months ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   52 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159326


Locations
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Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02159326    
Other Study ID Numbers: 17309
2014-000829-20 ( EudraCT Number )
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: August 14, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Ethinyl estradiol, levonorgestrel drug combination
Ethinyl Estradiol-Norgestrel Combination
Riociguat
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital