A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT01458210
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Ortho-Cyclen — DRUG
    Administered orally
  • Dulaglutide — BIOLOGICAL
    Administered subcutaneously

Study Details

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.

Key Dates

Start date
Oct 31, 2011
Status verified
Oct 2014
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

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

Arms

  • Experimental: Ortho-Cyclen (OC) Alone (Period 1); OC+Dulaglutide (Period 2)
    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.

Primary Outcome Measure

Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN) [ Time Frame: Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.DallasTexas--

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By research site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.· Dallas, TX

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