Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive

Contraception Clinical Trial

Official title:

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose, Combination Oral Contraceptive, Which Utilizes Ethinyl Estradiol During the Seven Day Interval Between Each 84-day Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196326
• Other study ID #: DR-PSE-309
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: February 4, 2010
• Start date: June 2005
• Est. completion date: June 2007

Study information

• Verified date: February 2010
• Source: Duramed Research
• 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 one year of oral contraceptive therapy with DR-1011. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2235
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 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-1011
1 tablet daily

Locations

Country	Name	City	State
United States	Duramed Investigational Site	Boise	Idaho
United States	Duramed Investigational Site	Charlotte	North Carolina
United States	Duramed Investigational Site	Chicago	Illinois
United States	Duramed Investigational Site	Colorado Springs	Colorado
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 Cables	Florida
United States	Duramed Investigational Site	Dallas	Texas
United States	Duramed Investigational Site	Decatur	Georgia
United States	Duramed Investigational Site	Denver	Colorado
United States	Duramed Investigational Site	Douglasville	Georgia
United States	Duramed Investigational Site	Hollywood	Florida
United States	Duramed Investigational Site	Houston	Texas
United States	Duramed Investigational Site	Huntsville	Alabama
United States	Duramed Investigational Site	Jacksonville	Florida
United States	Duramed Investigational Site	Kansas City	Missouri
United States	Duramed Investigational Site	Lakewood	Washington
United States	Duramed Investigational Site	Lawrenceville	New Jersey
United States	Duramed Investigational Site	Leesburg	Florida
United States	Duramed Investigational Site	Louisville	Kentucky
United States	Duramed Investigational Site	Medford	Oregon
United States	Duramed Investigational Site	Miami	Florida
United States	Duramed Investigational Site	Moorestown	New Jersey
United States	Duramed Investigational Site	New Brunswick	New Jersey
United States	Duramed Investigational Site	New London	Connecticut
United States	Duramed Investigational Site	Newport News	Virginia
United States	Duramed Investigational Site	Norfolk	Virginia
United States	Duramed Investigational Site	Oklahoma	Oklahoma
United States	Duramed Investigational Site	Palm Springs	Florida
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	Phoenix	Arizona
United States	Duramed Investigational Site	Pittsburgh	Pennsylvania
United States	Duramed Investigational Site	Pittsburgh	Pennsylvania
United States	Duramed Investigational Site	Richmond	Virginia
United States	Duramed Investigational Site	Rochester	New York
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	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. Louis	Missouri
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	Tucson	Arizona
United States	Duramed Investigational Site	Waco	Texas
United States	Duramed Investigational Site	Willow Grove	Pennsylvania
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, 

References & Publications (1)

Kroll R, Reape KZ, Margolis M. The efficacy and safety of a low-dose, 91-day, extended-regimen oral contraceptive with continuous ethinyl estradiol. Contraception. 2010 Jan;81(1):41-8. doi: 10.1016/j.contraception.2009.07.003. Epub . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate (Pearl Index)		After the onset of treatment and within 14 days after the last combination pill (approx. 1 year of treatment)	No
Secondary	Adverse Events Reported by Patients and Investigators		Up to one year	Yes