Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
Sponsor
Duramed Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00362479
Collaborator
(none)
1,347
85
1
11
15.8
1.4
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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 Design
Study Type:
Interventional
Actual Enrollment
:
1347 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021
Study Start Date
:
Aug 1, 2006
Actual Primary Completion Date
:
Jul 1, 2007
Actual Study Completion Date
:
Jul 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: DR-1021
1 tablet daily
|
Outcome Measures
Primary Outcome Measures
- Evaluation of pregnancy rates [Duration of study]
Secondary Outcome Measures
- Adverse events reported by patients and investigators [Duration of study]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Premenopausal
-
Not pregnant or breastfeeding
-
Sexually active at risk of pregnancy
Exclusion Criteria:
-
Any contraindication to the use of oral contraceptives
-
Pregnancy within the last 3 months
-
Smoking > 10 cigarettes per day
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duramed Investigational Site | Huntsville | Alabama | United States | 35801 |
| 2 | Duramed Investigational Site | Mobile | Alabama | United States | 36608 |
| 3 | Duramed Investigational Site | Phoenix | Arizona | United States | 85015 |
| 4 | Duramed Investigational Site | Phoenix | Arizona | United States | 85031 |
| 5 | Duramed Investigational Site | Carmichael | California | United States | 95608 |
| 6 | Duramed Investigational Site | Irvine | California | United States | 92618 |
| 7 | Duramed Investigational Site | San Diego | California | United States | 92108 |
| 8 | Duramed Investigational Site | San Diego | California | United States | 92123 |
| 9 | Duramed Investigational Site | San Ramon | California | United States | 94583 |
| 10 | Duramed Investigational Site | Colorado Springs | Colorado | United States | 80909 |
| 11 | Duramed Investigational Site | Lakewood | Colorado | United States | 80228 |
| 12 | Duramed Investigational Site | Wilmington | Delaware | United States | 19805 |
| 13 | Duramed Investigational Site | Washington | District of Columbia | United States | 20006 |
| 14 | Duramed Investigational Site | Aventura | Florida | United States | 33180 |
| 15 | Duramed Investigational Site | Boynton Beach | Florida | United States | 33437 |
| 16 | Duramed Investigational Site | Brooksville | Florida | United States | 33613 |
| 17 | Duramed Investigational Site | Clearwater | Florida | United States | 33761 |
| 18 | Duramed Investigational Site | Coral Gables | Florida | United States | 33134 |
| 19 | Duramed Investigational Site | Fort Meyers | Florida | United States | 33918 |
| 20 | Duramed Investigational Site | Leesburg | Florida | United States | 34748 |
| 21 | Duramed Investigational Site | Longwood | Florida | United States | 32779 |
| 22 | Duramed Investigational Site | Miami | Florida | United States | 33173 |
| 23 | Duramed Investigational Site | Pinellas Park | Florida | United States | 33781 |
| 24 | Duramed Investigational Site | Sarasota | Florida | United States | 34239 |
| 25 | Duramed Investigational Site | St. Petersburg | Florida | United States | 33702 |
| 26 | Duramed Investigational Site | St. Petersburg | Florida | United States | 33709 |
| 27 | Duramed Investigational Site | Tampa | Florida | United States | 33613 |
| 28 | Duramed Investigational Site | West Palm Beach | Florida | United States | 33409 |
| 29 | Duramed Investigational Site | Atlanta | Georgia | United States | 30328 |
| 30 | Duramed Investigational Site | Atlanta | Georgia | United States | 30342 |
| 31 | Duramed Investigational Site | Decatur | Georgia | United States | 30034 |
| 32 | Duramed Investigational Site | Roswell | Georgia | United States | 30075 |
| 33 | Duramed Investigational Site | Boise | Idaho | United States | 83704 |
| 34 | Duramed Investigational Site | Chicago | Illinois | United States | 60611 |
| 35 | Duramed Investigational Site | Chicago | Illinois | United States | 60612 |
| 36 | Duramed Investigational Site | Peoria | Illinois | United States | 61602 |
| 37 | Duramed Investigational Site | Shawnee Mission | Kansas | United States | 66216 |
| 38 | Duramed Investigational Site | Topeka | Kansas | United States | 66614 |
| 39 | Duramed Investigational Site | Lexington | Kentucky | United States | 40509 |
| 40 | Duramed Investigational Site | Louisville | Kentucky | United States | 40291 |
| 41 | Duramed Investigational Site | Mt Sterling | Kentucky | United States | 40353 |
| 42 | Duramed Investigational Site | Kansas City | Missouri | United States | 64108 |
| 43 | Duramed Investigational Site | Lincoln | Nebraska | United States | 68510 |
| 44 | Duramed Investigational Site | Las Vegas | Nevada | United States | 89146 |
| 45 | Duramed Investigational Site | Moorestown | New Jersey | United States | 08057 |
| 46 | Duramed Investigational Site | New Brunswick | New Jersey | United States | 08901 |
| 47 | Duramed Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 48 | Duramed Investigational Site | Johnson City | New York | United States | 13790 |
| 49 | Duramed Investigational Site | Rochester | New York | United States | 14609 |
| 50 | Duramed Investigational Site | Charlotte | North Carolina | United States | 28211 |
| 51 | Duramed Investigational Site | Raleigh | North Carolina | United States | 27612 |
| 52 | Duramed Investigational Site | Wilmington | North Carolina | United States | 28412 |
| 53 | Duramed Investigational Site | Winston-Salem | North Carolina | United States | 27103 |
| 54 | Duramed Investigational Site | Columbus | Ohio | United States | 43210 |
| 55 | Duramed Investigational Site | Columbus | Ohio | United States | 43213 |
| 56 | Duramed Investigational Site | Oklahoma City | Oklahoma | United States | 73112 |
| 57 | Duramed Investigational Site | Medford | Oregon | United States | 97504 |
| 58 | Duramed Investigational Site | Philadelphia | Pennsylvania | United States | 19114 |
| 59 | Duramed Investigational Site | Reading | Pennsylvania | United States | 19606 |
| 60 | Duramed Investigational Site | Cranston | Rhode Island | United States | 02920 |
| 61 | Duramed Investigational Site | Greer | South Carolina | United States | 29651 |
| 62 | Duramed Investigational Site | Mt Pleasant | South Carolina | United States | 29464 |
| 63 | Duramed Investigational Site | Bristol | Tennessee | United States | 37620 |
| 64 | Duramed Investigational Site | Chattanooga | Tennessee | United States | 37404 |
| 65 | Duramed Investigational Site | Clarksville | Tennessee | United States | 37043 |
| 66 | Duramed Investigational Site | Germantown | Tennessee | United States | 38138 |
| 67 | Duramed Investigational Site | Knoxville | Tennessee | United States | 37920 |
| 68 | Duramed Investigational Site | Nashville | Tennessee | United States | 37203 |
| 69 | Duramed Investigational Site | Austin | Texas | United States | 78759 |
| 70 | Duramed Investigational Site | Dallas | Texas | United States | 75234 |
| 71 | Duramed Investigational Site | Houston | Texas | United States | 77030 |
| 72 | Duramed Investigational Site | San Antonio | Texas | United States | 78229 |
| 73 | Duramed Investigational Site | Waco | Texas | United States | 76712 |
| 74 | Duramed Investigational Site | Magna | Utah | United States | 84044 |
| 75 | Duramed Investigational Site | Pleasant Grove | Utah | United States | 84062 |
| 76 | Duramed Investigational Site | Salt Lake City | Utah | United States | 84124 |
| 77 | Duramed Investigational Site | Sandy | Utah | United States | 84070 |
| 78 | Duramed Investigational Site | Arlington | Virginia | United States | 22203 |
| 79 | Duramed Investigational Site | Newport News | Virginia | United States | 23602 |
| 80 | Duramed Investigational Site | Norfolk | Virginia | United States | 23507 |
| 81 | Duramed Investigational Site | Richmond | Virginia | United States | 23233 |
| 82 | Duramed Investigational Site | Lakewood | Washington | United States | 98499 |
| 83 | Duramed Investigational Site | Seattle | Washington | United States | 98105 |
| 84 | Duramed Investigational Site | Spokane | Washington | United States | 99207 |
| 85 | Duramed Investigational Site | Tacoma | Washington | United States | 98405 |
Sponsors and Collaborators
- Duramed Research
Investigators
- Principal Investigator: Duramed Medical Monitor, Duramed Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00362479
Other Study ID Numbers:
- DR-DSG-301
First Posted:
Aug 10, 2006
Last Update Posted:
Aug 21, 2013
Last Verified:
Aug 1, 2013