A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
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.
Inclusion Criteria:
Exclusion Criteria:
Fort Meyers, Florida 33918, United States