Open-label Study to Evaluate the Efficacy and Safety of an Extended-cycle, Low Dose Combination Oral Contraceptive
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
1 other identifier
interventional
2,235
1 country
55
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedResults Posted
Study results publicly available
April 15, 2009
CompletedNovember 16, 2016
September 1, 2016
2 years
September 12, 2005
November 21, 2008
September 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 14 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 14 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 14 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
up to one year
Annualized Pregnancy Rate (Pearl Index) For 91-Day Cycles by Cohort Using up to 7 Days Post-Last Combination Dose When Defining "On Drug" Pregnancy
Pearl Index= ((100)\*(number of pregnancies)\*(4 cycles/year))/number of 91-day cycles completed. The pregnancy rate included "on-drug" pregnancies, defined as those pregnancies for which the date of conception was on or after the date of first dose of study medication, but no more than 7 days after the date of last combination dose of study medication. Pregnancy was defined as a positive pregnancy test verified by the study staff. The conception date was based on the ultrasound date. A pregnancy was not considered 'on drug' if conception clearly occurred prior to first dose of study medication, or more than 7 days after the date of last combination dose of study medication. Three denominators are reported; * excluding cycles where other birth control methods (BCMs) was used * all complete cycles * compliant-use (i.e. subject did not skip two or more consecutive pills or had a pattern of substantial non-compliance, or used a prohibited concomitant medication)
up to one year
Secondary Outcomes (1)
Participants With Treatment-Emergent Adverse Events
Day 1 up to one year
Study Arms (1)
DR-1011
EXPERIMENTALParticipants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
Interventions
Eighty-four orange, embossed tablets, each containing 100 μg levonorgestrel (LNG) / 20 μg ethinyl estradiol (EE) and 7 yellow, embossed tablets, each containing 10 μg of EE. One combination tablet was to be taken each day for 84 days followed by 7 days of EE tablets in 91-day cycles repeated consecutively for approximately one year (four 91-day cycles).
Eligibility Criteria
You may qualify if:
- Premenopausal
- Not pregnant or breastfeeding
- Sexually active at risk of pregnancy
You may not qualify if:
- Any contraindication to the use of oral contraceptives
- Pregnancy within the last 3 months
- Smoking \> 10 cigarettes per day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duramed Researchlead
Study Sites (55)
Duramed Investigational Site
Huntsville, Alabama, 35801, United States
Duramed Investigational Site
Phoenix, Arizona, 85013, United States
Duramed Investigational Site
Phoenix, Arizona, 85031, United States
Duramed Investigational Site
Phoenix, Arizona, 85032, United States
Duramed Investigational Site
Tucson, Arizona, 85712, United States
Duramed Investigational Site
San Diego, California, 92103, United States
Duramed Investigational Site
San Diego, California, 92108, United States
Duramed Investigational Site
Colorado Springs, Colorado, 80907, United States
Duramed Investigational Site
Colorado Springs, Colorado, 80909, United States
Duramed Investigational Site
Denver, Colorado, 80202, United States
Duramed Investigational Site
New London, Connecticut, 06320, United States
Duramed Investigational Site
Coral Cables, Florida, 33134, United States
Duramed Investigational Site
Hollywood, Florida, 33024, United States
Duramed Investigational Site
Jacksonville, Florida, 32216, United States
Duramed Investigational Site
Leesburg, Florida, 34748, United States
Duramed Investigational Site
Miami, Florida, 33143, United States
Duramed Investigational Site
Palm Springs, Florida, 33437, United States
Duramed Investigational Site
Sarasota, Florida, 34239, United States
Duramed Investigational Site
Tampa, Florida, 33607, United States
Duramed Investigational Site
Decatur, Georgia, 30034, United States
Duramed Investigational Site
Douglasville, Georgia, 30134, United States
Duramed Investigational Site
Boise, Idaho, 83704, United States
Duramed Investigational Site
Chicago, Illinois, 60611, United States
Duramed Investigational Site
Shawnee Mission, Kansas, 66216, United States
Duramed Investigational Site
Topeka, Kansas, 66614, United States
Duramed Investigational Site
Louisville, Kentucky, 40291, United States
Duramed Investigational Site
Kansas City, Missouri, 64106, United States
Duramed Investigational Site
St Louis, Missouri, 63110, United States
Duramed Investigational Site
Lawrenceville, New Jersey, 08648, United States
Duramed Investigational Site
Moorestown, New Jersey, 08057, United States
Duramed Investigational Site
New Brunswick, New Jersey, 08901, United States
Duramed Investigational Site
Rochester, New York, 14609, United States
Duramed Investigational Site
Charlotte, North Carolina, 28222, United States
Duramed Investigational Site
Wilmington, North Carolina, 28412, United States
Duramed Investigational Site
Winston-Salem, North Carolina, 27103, United States
Duramed Investigational Site
Columbus, Ohio, 43205, United States
Duramed Investigational Site
Columbus, Ohio, 43213, United States
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112, United States
Duramed Investigational Site
Medford, Oregon, 97504, United States
Duramed Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Duramed Investigational Site
Willow Grove, Pennsylvania, 19090, United States
Duramed Investigational Site
Dallas, Texas, 75390, United States
Duramed Investigational Site
Houston, Texas, 77030, United States
Duramed Investigational Site
San Antonio, Texas, 78229, United States
Duramed Investigational Site
Waco, Texas, 76712, United States
Duramed Investigational Site
Salt Lake City, Utah, 84124, United States
Duramed Investigational Site
Newport News, Virginia, 23602, United States
Duramed Investigational Site
Norfolk, Virginia, 23507, United States
Duramed Investigational Site
Richmond, Virginia, 23226, United States
Duramed Investigational Site
Lakewood, Washington, 98499, United States
Duramed Investigational Site
Seattle, Washington, 98105, United States
Duramed Investigational Site
Spokane, Washington, 99207, United States
Duramed Investigational Site
Tacoma, Washington, 98405, United States
Related 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.
PMID: 20004272RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- STUDY CHAIR
Duramed Protocol Chair
Duramed Research, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
June 1, 2005
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
November 16, 2016
Results First Posted
April 15, 2009
Record last verified: 2016-09