Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT01324505
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • semaglutide — DRUG
    Semaglutide will be administered once weekly by s.c. (under the skin) injections in the abdomen. A total of 13 doses of semaglutide will be administered according to a predefined dosing scheme
  • placebo — DRUG
    Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
  • Microgyn® — DRUG
    Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.

Study Details

This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.

Key Dates

Start date
Mar 31, 2011
Status verified
Feb 2017
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: One-sequence cross-over arm

Primary Outcome Measure

Area under the ethinylestradiol concentration-time curve [ Time Frame: in the 24 hour dosing interval ]

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