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
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