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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: SNAC Drug: Microgynon® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females
Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral contraceptive/SNAC/Oral Trial drug 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845219


Locations
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Germany
Novo Nordisk Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02845219     History of Changes
Other Study ID Numbers: NN9924-4249
2015-004232-35 ( EudraCT Number )
U1111-1174-7914 ( Other Identifier: WHO )
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Contraceptive Agents
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Combined