LivingGLP1
Study S000633

Effect of Tirzepatide on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

ClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT04172987
Study type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Phase
PHASE1
Masking
NONE
Status
COMPLETED
Enrollment
40
Start
2020-02-26
Primary completion
2021-02-09
Lead sponsor
Eli Lilly and Company
Conditions
Healthy
Interventions
DRUG:Tirzepatide; DRUG:EE/NGM
Results posted
TRUE
Individual participant data sharing
NO
Secondary identifiers
OTHER:I8F-MC-GPGR

Registered primary outcomes

  • Period 1 and Period 2, Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Ethinylestradiol (EE) [Period 1 and Period 2: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose]
  • Period 1 and Period 2, PK: Maximum Concentration (Cmax) of EE [Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose]
  • Period 1 and Period 2, PK: Area Under the Concentration Versus Time Curve (AUC) Within 1 Dosing Interval (AUC[0-tau]) of Norelgestromin (NGMN) [Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose]
  • Period 1 and Period 2, PK: Cmax of Norelgestromin (NGMN) [Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48 hours postdose]

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