Effect of Dulaglutide (LY2189265) on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

Registration

Registration

NCT01458210

Study type

INTERVENTIONAL

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

22

Start

2011-10

Primary completion

2012-02

Lead sponsor

Eli Lilly and Company

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG:Ortho-Cyclen; BIOLOGICAL:Dulaglutide

Results posted

TRUE

Secondary identifiers

OTHER:H9X-MC-GBCQ

Registered primary outcomes

• Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN) [Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose]
• Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN) [Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose]
• Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN) [Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose]
• Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE) [Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose]
• Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Ethinyl Estradiol (EE) [Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose]
• Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Ethinyl Estradiol (EE) [Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose]