Trial Condition(s):
Pharmacokinetics
Clinical study investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol
Bayer Identifier:
17004
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ssTimeframe: 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)}ssTimeframe: At different time points on day 21
- Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)Timeframe: At different time points upto 8 weeks
- Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)Timeframe: At different time points up to 8 weeks
- Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)Timeframe: At different time points up to 8 weeks
- Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)Timeframe: At different time points up to 8 weeks
Additional Information
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