check_circleStudy Completed
Pharmacokinetics
Bayer Identifier:
17004
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Clinical study investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol
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.
Key Participants Requirements
Sex
FemaleAge
18 - 45 YearsTrial summary
Enrollment Goal
16Trial Dates
June 2014 - March 2015Phase
Phase 1Could I Receive a placebo
NoProducts
Noristerat (BAY86-6308)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical Research Services Berlin GmbH | Berlin, 13353, Germany |
Primary Outcome
- Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ssdate_rangeTime Frame:At different time points on day 21enhanced_encryptionNoSafety Issue:
- Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ssdate_rangeTime Frame:At different time points on day 21enhanced_encryptionNoSafety Issue:
- Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)date_rangeTime Frame:At different time points upto 8 weeksenhanced_encryptionNoSafety Issue:
- Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)date_rangeTime Frame:At different time points up to 8 weeksenhanced_encryptionNoSafety Issue:
- Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)date_rangeTime Frame:At different time points up to 8 weeksenhanced_encryptionNoSafety Issue:
- Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)date_rangeTime Frame:At different time points up to 8 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
Basic ScienceAllocation
Non-randomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2