Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
Public ClinicalTrials.gov record NCT00196326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, single treatment study. All subjects will receive one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.
Study identification
- NCT ID
- NCT00196326
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,235 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 40 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2005 (Type not available)
- Primary completion
- Jun 2007 (Actual)
- Completion
- Jun 2007 (Actual)
- Last update posted
- Nov 16, 2016
2005 – 2007
United States locations
- U.S. sites
- 55
- U.S. states
- 23
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Duramed Investigational Site | Huntsville | Alabama | 35801 | — |
| Duramed Investigational Site | Phoenix | Arizona | 85013 | — |
| Duramed Investigational Site | Phoenix | Arizona | 85031 | — |
| Duramed Investigational Site | Phoenix | Arizona | 85032 | — |
| Duramed Investigational Site | Tucson | Arizona | 85712 | — |
| Duramed Investigational Site | San Diego | California | 92103 | — |
| Duramed Investigational Site | San Diego | California | 92108 | — |
| Duramed Investigational Site | Colorado Springs | Colorado | 80907 | — |
| Duramed Investigational Site | Colorado Springs | Colorado | 80909 | — |
| Duramed Investigational Site | Denver | Colorado | 80202 | — |
| Duramed Investigational Site | New London | Connecticut | 06320 | — |
| Duramed Investigational Site | Coral Cables | Florida | 33134 | — |
| Duramed Investigational Site | Hollywood | Florida | 33024 | — |
| Duramed Investigational Site | Jacksonville | Florida | 32216 | — |
| Duramed Investigational Site | Leesburg | Florida | 34748 | — |
| Duramed Investigational Site | Miami | Florida | 33143 | — |
| Duramed Investigational Site | Palm Springs | Florida | 33437 | — |
| Duramed Investigational Site | Sarasota | Florida | 34239 | — |
| Duramed Investigational Site | Tampa | Florida | 33607 | — |
| Duramed Investigational Site | Decatur | Georgia | 30034 | — |
| Duramed Investigational Site | Douglasville | Georgia | 30134 | — |
| Duramed Investigational Site | Boise | Idaho | 83704 | — |
| Duramed Investigational Site | Chicago | Illinois | 60611 | — |
| Duramed Investigational Site | Shawnee Mission | Kansas | 66216 | — |
| Duramed Investigational Site | Topeka | Kansas | 66614 | — |
| Duramed Investigational Site | Louisville | Kentucky | 40291 | — |
| Duramed Investigational Site | Kansas City | Missouri | 64106 | — |
| Duramed Investigational Site | St Louis | Missouri | 63110 | — |
| Duramed Investigational Site | Lawrenceville | New Jersey | 08648 | — |
| Duramed Investigational Site | Moorestown | New Jersey | 08057 | — |
| Duramed Investigational Site | New Brunswick | New Jersey | 08901 | — |
| Duramed Investigational Site | Rochester | New York | 14609 | — |
| Duramed Investigational Site | Charlotte | North Carolina | 28222 | — |
| Duramed Investigational Site | Wilmington | North Carolina | 28412 | — |
| Duramed Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| Duramed Investigational Site | Columbus | Ohio | 43205 | — |
| Duramed Investigational Site | Columbus | Ohio | 43213 | — |
| Duramed Investigational Site | Oklahoma City | Oklahoma | 73112 | — |
| Duramed Investigational Site | Medford | Oregon | 97504 | — |
| Duramed Investigational Site | Philadelphia | Pennsylvania | 19114 | — |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15206 | — |
| Duramed Investigational Site | Pittsburgh | Pennsylvania | 15213 | — |
| Duramed Investigational Site | Willow Grove | Pennsylvania | 19090 | — |
| Duramed Investigational Site | Dallas | Texas | 75390 | — |
| Duramed Investigational Site | Houston | Texas | 77030 | — |
| Duramed Investigational Site | San Antonio | Texas | 78229 | — |
| Duramed Investigational Site | Waco | Texas | 76712 | — |
| Duramed Investigational Site | Salt Lake City | Utah | 84124 | — |
| Duramed Investigational Site | Newport News | Virginia | 23602 | — |
| Duramed Investigational Site | Norfolk | Virginia | 23507 | — |
| Duramed Investigational Site | Richmond | Virginia | 23226 | — |
| Duramed Investigational Site | Lakewood | Washington | 98499 | — |
| Duramed Investigational Site | Seattle | Washington | 98105 | — |
| Duramed Investigational Site | Spokane | Washington | 99207 | — |
| Duramed Investigational Site | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00196326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 16, 2016 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00196326 live on ClinicalTrials.gov.