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Completed

NCT Number: NCT02845219

A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females

This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy postmenopausal females.

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Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Postmenopausal female, age at least 45 years at the time of signing informed consent. With at least 12 consecutive months since the last spontaneous menstrual bleeding (if there was any uncertainty of the time of the last spontaneous bleeding, the postmenopausal status is to be confirmed with follicle stimulating hormone (FSH) 40 mIU/mL)
  • Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive)
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

  • Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day). A subject smoking less than one cigarette or the equivalent per day must be able or willing to refrain from smoking and use of nicotine substitute products during the trial
  • Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
  • Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic. If white-coat hypertension is suspected a single repeat measurement is allowed, last measurement being conclusive
  • History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

Treatment and study plan

semaglutide

Drug

Oral administration once daily alone or together with oral contraceptive.

SNAC

Drug

Oral administration once daily together with oral contraceptive.

Microgynon®

Drug

Oral administration once daily alone or together with oral semaglutide or SNAC.

Primary outcomes

  1. Area under the ethinylestradiol plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

    Time frame: On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

  2. Area under the levonorgestrel plasma concentration-time curve during a dosing interval (0-24 hours) at steady state

    Time frame: On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

Secondary outcomes

  1. Maximum observed ethinylestradiol plasma concentration during a dosing interval (0-24 hours) at steady state

    Time frame: On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

  2. Maximum observed levonorgestrel plasma concentration during a dosing interval 0-24 hours) at steady state

    Time frame: On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2016
Registry last updated
Jun 7, 2017

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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