NCT02170038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

June 20, 2014

Last Update Submit

February 17, 2016

Conditions

Pharmacokinetics

Keywords

Drug Kinetics

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: Microgynon

Arm 2

EXPERIMENTAL

Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat

Drug: Noristerat(BAY86-6308)

Interventions

MicrogynonDRUG

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

Arm 1
Noristerat(BAY86-6308)DRUG

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

Arm 2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Interventions

ethinyl estradiol, levonorgestrel drug combination

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 23, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

February 18, 2016

Record last verified: 2016-02

Locations

DE(1)