NCT02845219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

July 13, 2016

Last Update Submit

June 6, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

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

    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

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

Secondary Outcomes (2)

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

    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

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

Study Arms (1)

Oral contraceptive/SNAC/Oral Trial drug

EXPERIMENTAL
Drug: semaglutideDrug: SNACDrug: Microgynon®

Interventions

semaglutideDRUG

Oral administration once daily alone or together with oral contraceptive.

Oral contraceptive/SNAC/Oral Trial drug
SNACDRUG

Oral administration once daily together with oral contraceptive.

Oral contraceptive/SNAC/Oral Trial drug
Microgynon®DRUG

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

Oral contraceptive/SNAC/Oral Trial drug

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

  • Jordy AB, Albayaty M, Breitschaft A, Anderson TW, Christiansen E, Houshmand-Oregaard A, Manigandan E, Baekdal TA. Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects. Clin Pharmacokinet. 2021 Sep;60(9):1171-1185. doi: 10.1007/s40262-020-00976-x.

    PMID: 33782832DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

semaglutideethinyl estradiol, levonorgestrel drug combination

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 27, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

DE(1)