This is an open-label, single treatment study. All subjects will receive 6 months of oral contraceptive therapy with DR-1021. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
The overall study duration for each patient will be approximately 8 months, which includes a screening period of approximately 4 weeks; a treatment period of approximately six months (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study drug.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,347
1 tablet daily
Evaluation of pregnancy rates
Time frame: Duration of study
Adverse events reported by patients and investigators
Time frame: Duration of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Duramed Investigational Site
Huntsville, Alabama, United States
Duramed Investigational Site
Mobile, Alabama, United States
Duramed Investigational Site
Phoenix, Arizona, United States
Duramed Investigational Site
Phoenix, Arizona, United States
Duramed Investigational Site
Carmichael, California, United States
Duramed Investigational Site
Irvine, California, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
San Diego, California, United States
Duramed Investigational Site
San Ramon, California, United States
Duramed Investigational Site
Colorado Springs, Colorado, United States
...and 75 more locations