Contraception Clinical Trial
Official title:
Open-Label Study of the Safety and Efficacy of a Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol
| Verified date | April 2013 |
| Source | Warner Chilcott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
| Status | Completed |
| Enrollment | 1683 |
| Est. completion date | September 2008 |
| Est. primary completion date | August 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Healthy Women - Age 18-45 - At risk for pregnancy - History of regular cycles Exclusion Criteria: - Contraindications for use of hormonal contraception - Conditions which affect the absorption or metabolism of steroid hormones - BMI > 35 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Warner Chilcott Investigational Site | Albuquerque | New Mexico |
| United States | Warner Chilcott Investigational Site | Berlin | New Jersey |
| United States | Warner Chilcott Investigational Site | Boynton Beach | Florida |
| United States | Warner Chilcott Investigational Site | Carmichael | California |
| United States | Warner Chilcott Investigational Site | Cary | North Carolina |
| United States | Warner Chilcott Investigational Site | Champaign | Illinois |
| United States | Warner Chilcott Investigational Site | Charleston | South Carolina |
| United States | Warner Chilcott Investigational Site | Clearwater | Florida |
| United States | Warner Chilcott Investigational Site | Cleveland | Ohio |
| United States | Warner Chilcott Investigational Site | Columbia | South Carolina |
| United States | Warner Chilcott Investigational Site | Columbus | Ohio |
| United States | Warner Chilcott Investigational Site | Dallas | Texas |
| United States | Warner Chilcott Investigational Site | Denver | Colorado |
| United States | Warner Chilcott Investigational Site | Greenville | South Carolina |
| United States | Warner Chilcott Investigational Site | Houston | Texas |
| United States | Warner Chilcott Investigational Site | Indianapolis | Indiana |
| United States | Warner Chilcott Investigational Site | Jacksonville | Florida |
| United States | Warner Chilcott Investigational Site | Lawrenceville | New Jersey |
| United States | Warner Chilcott Investigational Site | Leesburg | Florida |
| United States | Warner Chilcott Investigational Site | Lexington | Kentucky |
| United States | Warner Chilcott Investigational Site | Longwood | Florida |
| United States | Warner Chilcott Investigational Site | Louisville | Kentucky |
| United States | Warner Chilcott Investigational Site | Louisville | Kentucky |
| United States | Warner Chilcott Investigational Site | Magna | Utah |
| United States | Warner Chilcott Investigational Site | Miami | Florida |
| United States | Warner Chilcott Investigational Site | Miami | Florida |
| United States | Warner Chilcott Investigational Site | Moorestown | New Jersey |
| United States | Warner Chilcott Investigational Site | New Bern | North Carolina |
| United States | Warner Chilcott Investigational Site | New Port Richey | Florida |
| United States | Warner Chilcott Investigational Site | Norfolk | Virginia |
| United States | Warner Chilcott Investigational Site | Oklahoma City | Oklahoma |
| United States | Warner Chilcott Investigational Site | Pembroke Pines | Florida |
| United States | Warner Chilcott Investigational Site | Peoria | Illinois |
| United States | Warner Chilcott Investigational Site | Philadelphia | Pennsylvania |
| United States | Warner Chilcott Investigational Site | Phoenix | Arizona |
| United States | Warner Chilcott Investigational Site | Phoenix | Arizona |
| United States | Warner Chilcott Investigational Site | Phoenix | Arizona |
| United States | Warner Chilcott Investigational Site | Phoenix | Arizona |
| United States | Warner Chilcott Investigational Site | Pittsburgh | Pennsylvania |
| United States | Warner Chilcott Investigational Site | Plantation | Florida |
| United States | Warner Chilcott Investigational Site | Portland | Oregon |
| United States | Warner Chilcott Investigational Site | Portland | Oregon |
| United States | Warner Chilcott Investigational Site | Pottstown | Pennsylvania |
| United States | Warner Chilcott Investigational Site | Raleigh | North Carolina |
| United States | Warner Chilcott Investigational Site | Richmond | Virginia |
| United States | Warner Chilcott Investigational Site | Roswell | Georgia |
| United States | Warner Chilcott Investigational Site | Salt Lake City | Utah |
| United States | Warner Chilcott Investigational Site | Salt Lake City | Utah |
| United States | Warner Chilcott Investigational Site | San Antonio | Texas |
| United States | Warner Chilcott Investigational Site | San Diego | California |
| United States | Warner Chilcott Investigational Site | San Diego | California |
| United States | Warner Chilcott Investigational Site | Sandy | Utah |
| United States | Warner Chilcott Investigational Site | Sandy Springs | Georgia |
| United States | Warner Chilcott Investigational Site | Seattle | Washington |
| United States | Warner Chilcott Investigational Site | Spokane | Washington |
| United States | Warner Chilcott Investigational Site | St. Petersburg | Florida |
| United States | Warner Chilcott Investigational Site | Tacoma | Washington |
| United States | Warner Chilcott Investigational Site | Tempe | Arizona |
| United States | Warner Chilcott Investigational Site | Tempe | Arizona |
| United States | Warner Chilcott Investigational Site | Tucson | Arizona |
| United States | Warner Chilcott Investigational Site | Virginia Beach | Virginia |
| United States | Warner Chilcott Investigational Site | West Palm Beach | Florida |
| United States | Warner Chilcott Investigational Site | West Palm Beach | Florida |
| United States | Warner Chilcott Investigational Site | Wichita | Kansas |
| United States | Warner Chilcott Investigational Site | Winston-Salem | North Carolina |
| United States | Warner Chilcott Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Warner Chilcott |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18 to 35, MITT Population, | 13 cycles, 28 days each (1 year) | No | |
| Primary | Pregnancy Rate (Expressed as Pearl Index) in Women Aged 18-45, MITT Population | 13 Cycles, 28 days each (1 year) | No | |
| Secondary | Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 2, MITT Population | MITT Population | 2 Cycles, 28 days each (56 days) | Yes |
| Secondary | Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 6, MITT Population | MITT Population | 6 cycles, 28 days each (168 days) | Yes |
| Secondary | Number of Intracyclic Bleeding (IB)/Spotting Days Cycle 13, MITT Population | MITT Population | 13 cycles, 28 days each (1 year) | Yes |
| Secondary | Percentage of Subjects With Withdrawal Bleeding (%), Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) | No | |
| Secondary | Percentage of Subjects With Withdrawal Bleeding (%), Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) | No | |
| Secondary | Percentage of Subjects With Withdrawal Bleeding (%), Cycle 13, MITT Population | 13 cycles, 28 days each (1 year) | No | |
| Secondary | Median Duration of Withdrawal Bleeding, Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) | No | |
| Secondary | Median Duration of Withdrawal Bleeding, Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) | No | |
| Secondary | Median Duration of Withdrawal Bleeding, Cycle 12, MITT Population | 12 cycles, 28 days each (336 days) | No | |
| Secondary | Total Number of Bleeding Days Per Cycle, Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) | No | |
| Secondary | Total Number of Bleeding Days Per Cycle, Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) | No | |
| Secondary | Total Number of Bleeding Days Per Cycle, Cycle 13, MITT Population | 13 cycles, 28 days each (1 year) | No | |
| Secondary | Percentage of Subjects With Amenorrhea, Cycle 2, MITT Population | 2 cycles, 28 days each (56 days) | No | |
| Secondary | Percentage of Subjects With Amenorrhea, Cycle 6, MITT Population | 6 cycles, 28 days each (168 days) | No | |
| Secondary | Percentage of Subjects With Amenorrhea, Cycle 13, MITT Population | 13 cycles, 28 days each (1 year) | No |
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