Study of Safety and Efficacy of an Oral Contraceptive

Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE)

Sponsors

Lead Sponsor: Warner Chilcott

Source Warner Chilcott
Brief Summary

This is a 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 of norethindrone acetate/ethinyl estradiol (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the safety and tolerability of the product.

Overall Status Completed
Start Date January 2004
Completion Date November 2004
Primary Completion Date November 2004
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population 5.6 months (6 - 28 day cycles)
Secondary Outcome
Measure Time Frame
Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population 5.6 months (6 - 28 day cycles)
Enrollment 938
Condition
Intervention

Intervention Type: Drug

Intervention Name: Norethindrone Acetate/Ethinyl Estradiol 24 Days

Description: One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets

Arm Group Label: 24 Day NA/EE

Intervention Type: Drug

Intervention Name: Norethindrone Acetate /Ethinyl Estradiol 21 Days

Description: One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Arm Group Label: 21 Day NA/EE

Other Name: 21 Day NA/EE

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Herman Ellman, MD Study Director Sponsor GmbH
Location
Facility:
Warner Chilcott Investigational Site | Birmingham, Alabama, 35233, United States
Warner Chilcott Investigational Site | Phoenix, Arizona, 85014, United States
Warner Chilcott Investigational Site | Phoenix, Arizona, 85031, United States
Warner Chilcott Investigational Site | Chico, California, 95929, United States
Warner Chilcott Investigational Site | Los Angeles, California, 90033, United States
Warner Chilcott Investigational Site | San Diego, California, 92103, United States
Warner Chilcott Investigational Site | San Diego, California, 92108, United States
Warner Chilcott Investigational Site | Denver, Colorado, 80202, United States
Warner Chilcott Investigational Site | Boynton Beach, Florida, 33437, United States
Warner Chilcott Investigational Site | Jacksonville, Florida, 32207, United States
Warner Chilcott Investigational Site | Miami, Florida, 33186, United States
Warner Chilcott Investigational Site | Palm Harbor, Florida, 34684, United States
Warner Chilcott Investigational Site | Venice, Florida, 34285, United States
Warner Chilcott Investigational Site | West Palm Beach, Florida, 33409, United States
Warner Chilcott Investigational Site | Decatur, Georgia, 30033, United States
Warner Chilcott Investigational Site | Decatur, Georgia, 30034, United States
Warner Chilcott Investigational Site | Powder Springs, Georgia, 30127, United States
Warner Chilcott Investigational Site | Roswell, Georgia, 30075, United States
Warner Chilcott Investigational Site | Savannah, Georgia, 31405, United States
Warner Chilcott Investigational Site | Louisville, Kentucky, 40202, United States
Warner Chilcott Investigational Site | Kansas City, Missouri, 64112, United States
Warner Chilcott Investigational Site | St. Louis, Missouri, 63117, United States
Warner Chilcott Investigational Site | New Bern, North Carolina, 28562, United States
Warner Chilcott Investigational Site | Winston Salem, North Carolina, 27103, United States
Warner Chilcott Investigational Site | Allentown, Pennsylvania, 18104, United States
Warner Chilcott Investigational Site | Philadelphia, Pennsylvania, 19114, United States
Warner Chilcott Investigational Site | Pittsburgh, Pennsylvania, 15206, United States
Warner Chilcott Investigational Site | Charleston, South Carolina, 29425, United States
Warner Chilcott Investigational Site | Greenville, South Carolina, 29605, United States
Warner Chilcott Investigational Site | Sandy, Utah, 84070, United States
Warner Chilcott Investigational Site | Norfolk, Virginia, 23507, United States
Warner Chilcott Investigational Site | Richmond, Virginia, 23233, United States
Warner Chilcott Investigational Site | Virginia Beach, Virginia, 23456, United States
Warner Chilcott Investigational Site | Seattle, Washington, 98105, United States
Location Countries

United States

Verification Date

April 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: 24 Day NA/EE

Type: Experimental

Description: Norethindrone acetate 1 mg /ethinyl estradiol 20 mcg for 24 days of each 28 day cycle

Label: 21 Day NA/EE

Type: Active Comparator

Description: Norethindrone acetate 1 mg/ethinyl estradiol 20 mcg for 21 days of each 28 day cycle

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov