check_circleStudy Completed

Pharmacokinetics

Bayer Identifier:

17004

ClinicalTrials.gov Identifier:

NCT02170038

EudraCT Number:

2013-005280-89

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

Female

Age

18 - 45 Years
  • - 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

  • - - 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
16
Trial Dates
June 2014 - March 2015
Phase
Phase 1
Could I Receive a placebo
No
Products
Noristerat (BAY86-6308)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany

Primary Outcome

  • Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss
    date_rangeTime Frame:
    At different time points on day 21
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss
    date_rangeTime Frame:
    At different time points on day 21
    enhanced_encryption
    Safety Issue:
    No
  • Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)
    date_rangeTime Frame:
    At different time points upto 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)
    date_rangeTime Frame:
    At different time points up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)
    date_rangeTime Frame:
    At different time points up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)
    date_rangeTime Frame:
    At different time points up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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