A Study of Evacetrapib in Healthy Female Participants
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives (Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones found in the blood will be measured and compared when taken alone and when taken with evaceptrapib. Each woman will participate in two study periods. Information about any side effects that may occur will also be collected.
Key facts
- Study ID
- NCT01746732
- Run by
- Eli Lilly and Company
- People needed
- 23
- Starts
- 2012-12-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2018-10-09
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Are pre-menopausal females, and who are healthy as determined by medical history and physical examination
- Have a body mass index of 18 to 30 kilograms per square meter (kg/m\^2)
You may not qualify if…
- Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol and norgestimate), related compounds or any components of the formulation
- Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have taken injectable contraceptives within 12 months prior to the first dose of the lead-in period or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of the lead-in period
- Use of any tobacco- or nicotine-containing products within 6 months prior to the lead-in phase and during the study
Where it is running
- 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
Full record on ClinicalTrials.gov
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