Participate in a Birth Control Patch Research Study!

Recruiting
16 years - 35 years
Female
Phase 3
40 participants needed
1 Location

Brief description of study

The Women's Health Clinical Research Center at University of Pennsylvania is currently recruiting healthy women who have regular periods and do not wish to become pregnant for at least 12 months for a research study of an investigational birth control patch. The study patch that will be used in this study is experimental and being developed as a possible new method of birth control.).

Detailed description of study

The study drug looks like a square shaped Band Aid with rounded corners and is applied to the skin on the upper outer arm, stomach, buttock or back, in a place where it will not be rubbed by tight clothing. The study drugs will be absorbed through the skin. All qualified study participants will receive patches containing norelgestromin and ethinyl estradiol. Four (4) week (28 day) cycles will be used where a patch is applied and replaced every 7 days for 3 weeks in a row, followed by a 1 week "patch-free" period.

This study is to learn how effective the study drug is in preventing pregnancy and also to look at the safety and tolerability of wearing the patch. Healthy female participants of childbearing potential, aged at least 16 years old, who agree to be in this study will receive the transdermal patches containing norelgestromin and ethinyl estradiol. To take part in this study, you must be willing to use the study drug as your only form of birth control. You must be willing to engage in at least one act of heterosexual vaginal intercourse per month during the study period.

The study will last approximately 13 months and will involve 7 office visits with physical exams, pelvic exams, vital sign assessments, blood tests, pregnancy tests, STD tests, possibly a PAP smear, daily entry into an electronic diary. In addition, you will also be asked about your complete medical history, including your gynecological, menstrual, reproductive and sexual history. Participants need to be sexually active and be willing to use the study patch as their only method of birth control during their participation in the study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Healthy Volunteers
  • Age: 16 years - 35 years
  • Gender: Female

Participation in this study involves:
• 7 visits to the study site and 9 study phone calls
• physical and pelvic exams
• blood and urine sampling
• completion of a brief electronic daily diary application installed on your phone
• use of an investigational birth control patch and undertake home pregnancy tests
• Participants may be compensated for time and travel
 
For more information please click HERE: (insert Hyperlink or redcap address https://redcap.link/1c3vkvqc ) or call 215.662.7727.

Updated on 04 Aug 2024. Study ID: 850920

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