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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02845219 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4249Other id2015-004232-35Other idU1111-1174-7914Other id2015

Overview

Status
Completed
Phase
Phase 1
Enrollment
25 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Germany

Start
Jul 2016
Primary completion
Dec 2016
Completion
Dec 2016
First posted
27 Jul 2016 (estimated)
Last update posted
7 Jun 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017
  1. Ph 1

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

    NCT02845219

    Jul 2016 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • semaglutideDrug
  • SNACDrug
  • Microgynon®Drug

Arms1

  • Experimental

    Oral contraceptive/SNAC/Oral Trial drug

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(2)
  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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2021

9 results

Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects.

Jordy et al. 2021Clinical pharmacokineticscited by 19

PMID 33782832PMC8416862DOI 10.1007/s40262-020-00976-xPUB-33782832

Free to read · publisher termsCC BY-NC9 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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)

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