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Completed

NCT Number: NCT02170038

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

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, State of Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microgynon

Drug

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

Noristerat(BAY86-6308)

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax)

    Time frame: At different time points upto 8 weeks

  4. Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC)

    Time frame: At different time points up to 8 weeks

  5. Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax)

    Time frame: At different time points up to 8 weeks

  6. Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC)

    Time frame: At different time points up to 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 23, 2014
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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