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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170038
• Other study ID #: 17004
• Secondary ID: 2013-005280-89
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2014
• Last updated: February 17, 2016
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Microgynon
Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol.
• Noristerat(BAY86-6308)
Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss		At different time points on day 21	No
Primary	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	No
Primary	Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)		At different time points upto 8 weeks	No
Primary	Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)		At different time points up to 8 weeks	No
Primary	Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)		At different time points up to 8 weeks	No
Primary	Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)		At different time points up to 8 weeks	No

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