Seeking Healthy Volunteers for Non-Hormonal IUD Research
Brief description of study
This study is being conducted at the University of Pennsylvania to research a non-hormonal contraceptive IUD that is placed in the uterus and is intended to prevent pregnancy. This device is investigational and is being developed as a possible method of long-acting reversible contraception. “Investigational” means that IUD has not yet been approved by the Food and Drug Administration (FDA) for sale in the United States. It is similar to the ParaGard IUD, which is FDA approved.
The study will investigate the safety and effectiveness of the investigational IUD in preventing pregnancy as compared to the ParaGard IUD. We will also be looking at any effects on menstrual cycle periods and bleeding, and assess any side effects. Study participation involves about 8 visits over 38 months, as well as 4 telephone calls and, for the first year, completion of a daily diary chart.
Detailed description of study
Qualified participants:
• Healthy women ages 16 - 40
• Have regular menstrual periods every 21-35 days
• Willing to use the study device as their method of birth control
• Not seeking pregnancy for about three years
• Sexually active
Qualified participants will receive:
• Medical exams
• $25-100 per completed study visit ($625 completing every part of the study)
• A non-hormonal IUD
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
contraception
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Age: Between 16 Years - 40 Years
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Gender: Female
Updated on
02 Oct 2017.
Study ID: TX4807