Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02170038

Enrollment

Registered

2014-06-23

Start date

2014-06-30

Completion date

2015-03-31

Last updated

2016-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Keywords

Drug Kinetics

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.

Interventions

DRUGMicrogynon

Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol.

DRUGNoristerat(BAY86-6308)

Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss	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)}ss	At different time points on day 21
Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)	At different time points upto 8 weeks
Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)	At different time points up to 8 weeks
Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)	At different time points up to 8 weeks
Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)	At different time points up to 8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026