| Trial ID: | L3885 |
| Source ID: | NCT01458210
|
| Associated Drug: |
Ortho-Cyclen
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| Title: |
A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01458210/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Ortho-Cyclen|BIOLOGICAL: Dulaglutide
|
| Outcome Measures: |
Primary: 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 |
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| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
FEMALE
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| Age: |
ADULT
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| Phases: |
PHASE1
|
| Enrollment: |
22
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2011-10
|
| Completion Date: |
2012-02
|
| Results First Posted: |
2014-10-08
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| Last Update Posted: |
2014-10-08
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| Locations: |
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, Texas, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01458210
|
