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

Study Overview
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Brief Summary
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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.

Official Title
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Open Label, One-way Crossover Study to Assess the in Vivo Formation of Ethinylestradiol Following Single Intramuscular Administration of 200 mg Norethisterone Enantate Compared to Ethinylestradiol Pharmacokinetics After Multiple Doses of a Combined Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Women

Conditions
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Pharmacokinetics

Intervention / Treatment
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* Drug: Microgynon
* Drug: Noristerat(BAY86-6308)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Healthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days | Drug: Microgynon<br>* Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol.<br>|
| Experimental: Arm 2<br>Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat | Drug: Noristerat(BAY86-6308)<br>* Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Kinetics