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Completed

NCT Number: NCT02159326

Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

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.

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Key information

Conditions

Drug Interactions

Age range

52 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microgynon

Drug

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

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

Primary outcomes

  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 outcomes

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

    Time frame: Up to 4 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2014
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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