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Microgynon

Phase 3

Drug Interactions | Small molecule | Other |Bayer AG|Trials Updated: Aug 14, 2015

Microgynon development status

Highest phase Phase 3 (NCT00764881)
Phase scored for BAYRYPhase 1
Registered trials 11 across 6 sponsors since Oct 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Microgynon clinical trials

Microgynon · 1 trial · 1 indication

Phase 1 1
NCT02159326Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal WomenDrug Interactions
COMPLETED31 Analytics
PHASE1COMPLETED
Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women
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Study Endpoints

Primary Endpoints

Area under the plasma concentration time curve (AUC) of Ethinylestradiol (EE)
Up to 4 months

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

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 Endpoints

Number of participants with adverse events as a measure of safety and tolerability
Up to 4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Arm1EXPERIMENTALsingle oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
Arm2EXPERIMENTALmultiple 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)

Interventions

NameTypeDescription
MicrogynonDRUGsingle oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
Riociguat (Adempas,BAY63-2521)DRUGmultiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment
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Eligibility Criteria

Age Range52 Years to 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

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 (n...

Countries:Germany
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Frequently asked questions about Microgynon

What is Microgynon?

Microgynon is a small molecule drug developed by Bayer AG. It has been studied in the context of drug interactions, specifically in a Phase 1 trial involving healthy postmenopausal women. The drug is not approved for the studied indication and remains investigational.

What is Microgynon used for in drug interactions?

Microgynon was evaluated in a drug interaction study to assess its effects when co-administered with riociguat. The study was conducted in healthy postmenopausal women to investigate potential interactions. The results of this study are not detailed here.

Who makes Microgynon?

Microgynon is developed by Bayer AG, a multinational pharmaceutical company. Bayer AG trades on the OTC market under the ticker BAYRY. The company is responsible for the clinical development of Microgynon.

What phase is Microgynon in?

Microgynon is in Phase 1 clinical development. A Phase 1 trial has been completed, but no active trials are currently listed. The drug has not been approved for any indication and remains investigational.

What clinical trials is Microgynon in?

Microgynon has been studied in one completed clinical trial: NCT02159326, titled 'Microgynon Riociguat Drug Interaction Study in Healthy Postmenopausal Women.' This Phase 1 trial enrolled 31 participants in Germany and was completed.