This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
Time frame: Duration of Study
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Duramed Investigational Site
Phoenix, Arizona, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
Miami, Florida, United States
Duramed Investigational Site
Tampa, Florida, United States
Duramed Investigational Site
Augusta, Georgia, United States
Duramed Investigational Site
Savannah, Georgia, United States
Duramed Investigational Site
Boise, Idaho, United States
Duramed Investigational Site
Chicago, Illinois, United States
Duramed Investigational Site
Wichita, Kansas, United States
...and 25 more locations