Study 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

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

June 2014 - March 2015

Phase

Phase 1

Could I Receive a placebo

Products

Noristerat (BAY86-6308)

Accepts Healthy Volunteer

Yes

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

Additional Information

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