Study of Safety and Efficacy of an Oral Contraceptive

Contraception Clinical Trial

Official title:

An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477633
• Other study ID #: PR-00207
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2007
• Last updated: April 15, 2013
• Start date: June 2007
• Est. completion date: February 2009

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Norethindrone/ethinyl estradiol
1 tablet per day

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Site	Amite	Louisiana
United States	Warner Chilcott Investigational Site	Arkansas City	Kansas
United States	Warner Chilcott Investigational Site	Austin	Texas
United States	Warner Chilcott Investigational Site	Austin	Texas
United States	Warner Chilcott Investigational Site	Berlin	New Jersey
United States	Warner Chilcott Investigational Site	Boynton Beach	Florida
United States	Warner Chilcott Investigational Site	Brooksville	Florida
United States	Warner Chilcott Investigational Site	Cary	North Carolina
United States	Warner Chilcott Investigational Site	Castle Rock	Colorado
United States	Warner Chilcott Investigational Site	Champaign	Illinois
United States	Warner Chilcott Investigational Site	Chandler	Arizona
United States	Warner Chilcott Investigational Site	Chaska	Minnesota
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	Dallas	Texas
United States	Warner Chilcott Investigational Site	Decatur	Georgia
United States	Warner Chilcott Investigational Site	Denver	Colorado
United States	Warner Chilcott Investigational Site	Edison	New Jersey
United States	Warner Chilcott Investigational Site	Gainesville	Florida
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	Lakewood	Colorado
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	Louisville	Kentucky
United States	Warner Chilcott Investigational Site	Magna	Utah
United States	Warner Chilcott Investigational Site	Marrero	Louisiana
United States	Warner Chilcott Investigational Site	Medford	Oregon
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 York	New York
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	Pittsburgh	Pennsylvania
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	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	St. Petersburg	Florida
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	Vista	California
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	West Valley City	Utah
United States	Warner Chilcott Investigational Site	Wichita	Kansas
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	Pearl Index, 18-35 Years, MITT Population	Pregnancy rate in women 18-35 years old, Pearl Index - number of pregnancies per 100 women-years of treatment	13 cycles (28 days each), approximately 364 days	No
Secondary	Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population		12 cycles (28 days each), approximately 336 days	No
Secondary	Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population	Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain "mean median duration" of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode - median duration = duration of that episode, 2 episodes - median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated.	12 cycles (28 days each), approximately 336 days	No