Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Duramed Research |
---|---|
Information provided by: | Duramed Research |
ClinicalTrials.gov Identifier: | NCT00362479 |
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.
Condition | Intervention | Phase |
---|---|---|
Contraception |
Drug: DR-1021 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021 |
Enrollment: | 1347 |
Study Start Date: | August 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: DR-1021
1 tablet daily
|
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Duramed Medical Monitor | Duramed Research |
Responsible Party: | Duramed Research, Inc. ( Duramed Protocol Chair ) |
Study ID Numbers: | DR-DSG-301 |
Study First Received: | August 9, 2006 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00362479 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pregnancy prevention oral contraceptives |
Contraceptive Agents Contraceptives, Oral Contraceptive Agents, Female |
Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs Contraceptives, Oral |
Contraceptive Agents, Female Reproductive Control Agents Pharmacologic Actions |