Study of Safety and Efficacy of an Oral Contraceptive

Prevention of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932321
• Other study ID #: PR-03903
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2009
• Last updated: April 15, 2013
• Start date: January 2004
• Est. completion date: November 2004

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 938
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prevention of Pregnancy

Intervention

Drug:
• Norethindrone Acetate/Ethinyl Estradiol 24 Days
One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets
• Norethindrone Acetate /Ethinyl Estradiol 21 Days
One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Site	Allentown	Pennsylvania
United States	Warner Chilcott Investigational Site	Birmingham	Alabama
United States	Warner Chilcott Investigational Site	Boynton Beach	Florida
United States	Warner Chilcott Investigational Site	Charleston	South Carolina
United States	Warner Chilcott Investigational Site	Chico	California
United States	Warner Chilcott Investigational Site	Decatur	Georgia
United States	Warner Chilcott Investigational Site	Decatur	Georgia
United States	Warner Chilcott Investigational Site	Denver	Colorado
United States	Warner Chilcott Investigational Site	Greenville	South Carolina
United States	Warner Chilcott Investigational Site	Jacksonville	Florida
United States	Warner Chilcott Investigational Site	Kansas City	Missouri
United States	Warner Chilcott Investigational Site	Los Angeles	California
United States	Warner Chilcott Investigational Site	Louisville	Kentucky
United States	Warner Chilcott Investigational Site	Miami	Florida
United States	Warner Chilcott Investigational Site	New Bern	North Carolina
United States	Warner Chilcott Investigational Site	Norfolk	Virginia
United States	Warner Chilcott Investigational Site	Palm Harbor	Florida
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	Pittsburgh	Pennsylvania
United States	Warner Chilcott Investigational Site	Powder Springs	Georgia
United States	Warner Chilcott Investigational Site	Richmond	Virginia
United States	Warner Chilcott Investigational Site	Roswell	Georgia
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	Savannah	Georgia
United States	Warner Chilcott Investigational Site	Seattle	Washington
United States	Warner Chilcott Investigational Site	St. Louis	Missouri
United States	Warner Chilcott Investigational Site	Venice	Florida
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	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate (Expressed as Pearl Index) for Women 18 to 45 Years Old, MITT Population	Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment	5.6 months (6 - 28 day cycles)	No
Secondary	Mean Number of Intracyclic Bleeding (IB)/Spotting Days in Cycles 2-6, MITT Population	Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting.	5.6 months (6 - 28 day cycles)	No