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

Sponsor
Novo Nordisk A/S
Study ID
NCT02845219
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 31, 2016
Status verified
Jun 2017
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Oral contraceptive/SNAC/Oral Trial drug

Primary Outcome Measure

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) ]

Related Studies