Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Microgynon; Drug: Noristerat(BAY86-6308)

• Registration Number: NCT02170038
• Lead Sponsor: Bayer

Brief Summary

The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• Healthy female subject
• Age: 18 to 45 years (inclusive) at the first screening examination / visit
• Body mass index (BMI): above or equal 18 and below or equal 30 kg / m²
• At least 3 months since delivery, abortion, or lactation before the first screening examination / visit

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Exclusion Criteria

• • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
• Liver diseases, kidney diseases, metabolic disorders, thyroid disorders and known or suspected malignant or benign tumors
• Presence or a history of venous or arterial thrombotic/thromboembolic events
• Migraine with neurologic symptoms (complicated migraine)
• Clinically significant depression
• Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
• Use of systemic or topical medicines or substances which oppose the study objectives or which might influence them

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Microgynon	Healthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days
Arm 2	Noristerat(BAY86-6308)	Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat

Primary Outcome Measures

Name	Time	Method
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss	At different time points on day 21
Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss	At different time points on day 21
Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)	At different time points up to 8 weeks
Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)	At different time points up to 8 weeks
Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)	At different time points upto 8 weeks
Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)	At different time points up to 8 weeks