This open-label, non-randomized study will compare the strapped Femcap with the data from the Femcap arm of phase II/III study of the original Femcap with respect to removal difficulties, dislodgments, subject and partner genital pain or discomfort, cervical/vaginal discomfort. The goal of the study is to confirm that the final design of the device significantly improves ease of removal, but doses not increase dislodgments. Subjects will be seen for a screening visit including consent, medical history and pelvic exam including gc, chlamydia and pap tests. They will be scheduled to return in 2 weeks time for enrollment into the study. At enrollment, subjects will have colposcopy to rule out significant genital lesions, and then will be instructed in insertion and removal of the device. Those who cannot insert and remove the device at this visit will be terminated from the study. Those who continue will return at 2 weeks and 6 weeks for colposcopy. Subjects will be asked to demonstrate correct insertion and removal at the 2 week visit. Acceptability questionnaires will be administered to both partners at the 2nd and 6 week visits.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000056-39
Application #
6409190
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Type
DUNS #
053785812
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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