Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive

Contraception Clinical Trial

Official title:

A Prospective, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of the 28-Day Oral Contraceptive DR-1021

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362479
• Other study ID #: DR-DSG-301
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2006
• Last updated: August 20, 2013
• Start date: August 2006
• Est. completion date: July 2007

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1347
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

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:
• DR-1021
1 tablet daily

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Albuquerque	New Mexico
United States	Duramed Investigational Site	Arlington	Virginia
United States	Duramed Investigational Site	Atlanta	Georgia
United States	Duramed Investigational Site	Atlanta	Georgia
United States	Duramed Investigational Site	Austin	Texas
United States	Duramed Investigational Site	Aventura	Florida
United States	Duramed Investigational Site	Boise	Idaho
United States	Duramed Investigational Site	Boynton Beach	Florida
United States	Duramed Investigational Site	Bristol	Tennessee
United States	Duramed Investigational Site	Brooksville	Florida
United States	Duramed Investigational Site	Carmichael	California
United States	Duramed Investigational Site	Charlotte	North Carolina
United States	Duramed Investigational Site	Chattanooga	Tennessee
United States	Duramed Investigational Site	Chicago	Illinois
United States	Duramed Investigational Site	Chicago	Illinois
United States	Duramed Investigational Site	Clarksville	Tennessee
United States	Duramed Investigational Site	Clearwater	Florida
United States	Duramed Investigational Site	Colorado Springs	Colorado
United States	Duramed Investigational Site	Columbus	Ohio
United States	Duramed Investigational Site	Columbus	Ohio
United States	Duramed Investigational Site	Coral Gables	Florida
United States	Duramed Investigational Site	Cranston	Rhode Island
United States	Duramed Investigational Site	Dallas	Texas
United States	Duramed Investigational Site	Decatur	Georgia
United States	Duramed Investigational Site	Fort Meyers	Florida
United States	Duramed Investigational Site	Germantown	Tennessee
United States	Duramed Investigational Site	Greer	South Carolina
United States	Duramed Investigational Site	Houston	Texas
United States	Duramed Investigational Site	Huntsville	Alabama
United States	Duramed Investigational Site	Irvine	California
United States	Duramed Investigational Site	Johnson City	New York
United States	Duramed Investigational Site	Kansas City	Missouri
United States	Duramed Investigational Site	Knoxville	Tennessee
United States	Duramed Investigational Site	Lakewood	Washington
United States	Duramed Investigational Site	Lakewood	Colorado
United States	Duramed Investigational Site	Las Vegas	Nevada
United States	Duramed Investigational Site	Leesburg	Florida
United States	Duramed Investigational Site	Lexington	Kentucky
United States	Duramed Investigational Site	Lincoln	Nebraska
United States	Duramed Investigational Site	Longwood	Florida
United States	Duramed Investigational Site	Louisville	Kentucky
United States	Duramed Investigational Site	Magna	Utah
United States	Duramed Investigational Site	Medford	Oregon
United States	Duramed Investigational Site	Miami	Florida
United States	Duramed Investigational Site	Mobile	Alabama
United States	Duramed Investigational Site	Moorestown	New Jersey
United States	Duramed Investigational Site	Mt Pleasant	South Carolina
United States	Duramed Investigational Site	Mt Sterling	Kentucky
United States	Duramed Investigational Site	Nashville	Tennessee
United States	Duramed Investigational Site	New Brunswick	New Jersey
United States	Duramed Investigational Site	Newport News	Virginia
United States	Duramed Investigational Site	Norfolk	Virginia
United States	Duramed Investigational Site	Oklahoma City	Oklahoma
United States	Duramed Investigational Site	Peoria	Illinois
United States	Duramed Investigational Site	Philadelphia	Pennsylvania
United States	Duramed Investigational Site	Phoenix	Arizona
United States	Duramed Investigational Site	Phoenix	Arizona
United States	Duramed Investigational Site	Pinellas Park	Florida
United States	Duramed Investigational Site	Pleasant Grove	Utah
United States	Duramed Investigational Site	Raleigh	North Carolina
United States	Duramed Investigational Site	Reading	Pennsylvania
United States	Duramed Investigational Site	Richmond	Virginia
United States	Duramed Investigational Site	Rochester	New York
United States	Duramed Investigational Site	Roswell	Georgia
United States	Duramed Investigational Site	Salt Lake City	Utah
United States	Duramed Investigational Site	San Antonio	Texas
United States	Duramed Investigational Site	San Diego	California
United States	Duramed Investigational Site	San Diego	California
United States	Duramed Investigational Site	San Ramon	California
United States	Duramed Investigational Site	Sandy	Utah
United States	Duramed Investigational Site	Sarasota	Florida
United States	Duramed Investigational Site	Seattle	Washington
United States	Duramed Investigational Site	Shawnee Mission	Kansas
United States	Duramed Investigational Site	Spokane	Washington
United States	Duramed Investigational Site	St. Petersburg	Florida
United States	Duramed Investigational Site	St. Petersburg	Florida
United States	Duramed Investigational Site	Tacoma	Washington
United States	Duramed Investigational Site	Tampa	Florida
United States	Duramed Investigational Site	Topeka	Kansas
United States	Duramed Investigational Site	Waco	Texas
United States	Duramed Investigational Site	Washington	District of Columbia
United States	Duramed Investigational Site	West Palm Beach	Florida
United States	Duramed Investigational Site	Wilmington	Delaware
United States	Duramed Investigational Site	Wilmington	North Carolina
United States	Duramed Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duramed Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pregnancy rates		Duration of study	No
Secondary	Adverse events reported by patients and investigators		Duration of study	Yes