Conditions: Diabetes Mellitus, Type 2
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 22
Healthy volunteers: yes

Brief summary:
The purpose of this study is to look at how the body processes oral contraceptive (OC), using Ortho-Cyclen, as a commonly prescribed combination oral contraceptive in healthy female participants, and the effect of dulaglutide on how Ortho-Cyclen is processed by the body. Information about any side effects that may occur will also be collected.

Detailed description:

Arms:
arm 1: Ortho-Cyclen (OC) (0.25 milligram \[mg\] norelgestromin \[NGMN\] + 0.035 mg ethinyl estradiol \[EE\] \[active tablets\] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course and the Period 2 sample was taken during the second 28-day course.

Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2.

Interventions: intervention 1: Ortho-Cyclen intervention 2: Dulaglutide
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered subcutaneously

Protocol document: