Clinical trial NCT02170038: Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Drug Kinetics
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
timeFrame: At different time points on day 21
measure: Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss
timeFrame: At different time points on day 21
measure: Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)
timeFrame: At different time points upto 8 weeks
measure: Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)
timeFrame: At different time points up to 8 weeks
measure: Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)
timeFrame: At different time points up to 8 weeks
measure: Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)
timeFrame: At different time points up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: