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Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Interactions

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

Phase: Phase 1

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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

Primary outcome:

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

Area under the plasma concentration time curve (AUC) of Levonorgestrel (LNG)

Maximal concentration (Cmax) of Ethinylestradiol (EE)

Maximal concentration (Cmax) of Levonorgestrel (LNG)

Secondary outcome: Number of participants with adverse events as a measure of safety and tolerability

Eligibility

Minimum age: 52 Years. Maximum age: 65 Years. Gender(s): Female.

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

Locations and Contacts

Mönchengladbach, Nordrhein-Westfalen 41061, Germany
Additional Information

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Starting date: June 2014
Last updated: August 13, 2015

Page last updated: August 23, 2015

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