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Trial record 84 of 404 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT02845219
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE July 13, 2016
First Posted Date  ICMJE July 27, 2016
Last Update Posted Date June 7, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02845219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2016)
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females
Official Title  ICMJE A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: semaglutide
    Oral administration once daily alone or together with oral contraceptive.
  • Drug: SNAC
    Oral administration once daily together with oral contraceptive.
  • Drug: Microgynon®
    Oral administration once daily alone or together with oral semaglutide or SNAC.
Study Arms  ICMJE Experimental: Oral contraceptive/SNAC/Oral Trial drug
Interventions:
  • Drug: semaglutide
  • Drug: SNAC
  • Drug: Microgynon®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02845219
Other Study ID Numbers  ICMJE NN9924-4249
2015-004232-35 ( EudraCT Number )
U1111-1174-7914 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP