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

NCT ID: NCT02170038

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-03-31

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.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1

Healthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days

Group Type: EXPERIMENTAL

Microgynon

Intervention Type: DRUG

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

Arm 2

Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat

Group Type: EXPERIMENTAL

Noristerat(BAY86-6308)

Intervention Type: DRUG

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

Interventions

Microgynon

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

Intervention Type: DRUG

Noristerat(BAY86-6308)

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

2013-005280-89

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

17004

Identifier Type: -

Identifier Source: org_study_id