A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen
1 other identifier
interventional
567
1 country
50
Brief Summary
This is a 4-arm study to evaluate and compare bleeding patterns between three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive. 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_2
Started Oct 2006
Shorter than P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 30, 2006
CompletedFirst Posted
Study publicly available on registry
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
June 19, 2013
CompletedJuly 26, 2013
July 1, 2013
1.4 years
October 30, 2006
April 25, 2013
July 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84)
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Day 1-84
Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176)
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
Day 92-176
Secondary Outcomes (10)
Days With Bleeding During Active Cycle 1 (Day 1-84)
Day 1-84
Days With Bleeding During Active Cycle 2 (Day 92-176)
Day 92-176
Time to First Bleeding Day
Day 1-84
Maximum Bleeding Severity During Active Cycle 1 (Day 1-84)
Day 1-84
Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91)
Day 85-91
- +5 more secondary outcomes
Other Outcomes (2)
Number of Moderate to Heavy Bleeding Days During Active Cycle 1 (Day 1-84)
Day 1-84
Number of Moderate to Heavy Bleeding Days During Active Cycle 2 (Day 92-176)
Day 92-176
Study Arms (4)
Low Dose DR-1031
EXPERIMENTAL42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
Midrange Dose DR-1031
EXPERIMENTAL21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
High Dose DR-1031
EXPERIMENTAL21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
Seasonale
ACTIVE COMPARATOR84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
Interventions
Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.
84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.
Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Eligibility Criteria
You may qualify if:
- Premenopausal
- Not pregnant or breastfeeding
- Agree to use back-up non-hormonal contraception for study period
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 (50)
Duramed Investigational Site
Huntsville, Alabama, 35801, United States
Duramed Investigational Site
Tucson, Arizona, 85741, United States
Duramed Investigational Site
Little Rock, Arkansas, 72205, United States
Duramed Investigational Site
San Diego, California, 92108, United States
Duramed Investigational Site
San Francisco, California, 94102, United States
Duramed Investigational Site
Santa Ana, California, 92705, United States
Duramed Investigational Site
Vista, California, 92083, United States
Duramed Investigational Site
Pueblo, Colorado, 81001, United States
Duramed Investigational Site
Stratford, Connecticut, 06615, United States
Duramed Investigational Site
DeLand, Florida, 32720, United States
Duramed Investigational Site
Jacksonville, Florida, 32207, United States
Duramed Investigational Site
Melbourne, Florida, 32935, United States
Duramed Investigational Site
Miami, Florida, 33186, United States
Duramed Investigational Site
Tampa, Florida, 33607, United States
Duramed Investigational Site
West Palm Beach, Florida, 33401, United States
Duramed Investigational Site
West Palm Beach, Florida, 33407, United States
Duramed Investigational Site
Alpharetta, Georgia, 30005, United States
Duramed Investigational Site
Douglasville, Georgia, 30134, United States
Duramed Investigational Site
Savannah, Georgia, 31406, United States
Duramed Investigational Site
Boise, Idaho, 83712, United States
Duramed Investigational Site
Meridian, Idaho, 83642, United States
Duramed Investigational Site
Fort Wayne, Indiana, 46825, United States
Duramed Investigational Site
Wichita, Kansas, 67205, United States
Duramed Investigational Site
Baton Rouge, Louisiana, 70808, United States
Duramed Investigational Site
Metairie, Louisiana, 70006, United States
Duramed Investigational Site
Shreveport, Louisiana, 71106, United States
Duramed Investigational Site
Riverdale, Maryland, 20737, United States
Duramed Investigational Site
Kansas City, Missouri, 64114, United States
Duramed Investigational Site
Las Vegas, Nevada, 89109, United States
Duramed Investigational Site
Las Vegas, Nevada, 89128, United States
Duramed Investigational Site
North Las Vegas, Nevada, 89030, United States
Duramed Investigational Site
Lebanon, New Hampshire, 03756, United States
Duramed Investigational Site
Cary, North Carolina, 27511, United States
Duramed Investigational Site
New Bern, North Carolina, 28562, United States
Duramed Investigational Site
Winston-Salem, North Carolina, 27103, United States
Duramed Investigational Site
Cleveland, Ohio, 44122, United States
Duramed Investigational Site
Mayfield Heights, Ohio, 44124, United States
Duramed Investigational Site
Eugene, Oregon, 97401, United States
Duramed Investigational Site
Medford, Oregon, 97504, United States
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15206, United States
Duramed Investigational Site
Charleston, South Carolina, 29425, United States
Duramed Investigational Site
Columbia, South Carolina, 29201, United States
Duramed Investigational Site
Hilton Head Island, South Carolina, 29926, United States
Duramed Investigational Site
Jackson, Tennessee, 38305, United States
Duramed Investigational Site
Austin, Texas, 78737, United States
Duramed Investigational Site
Dallas, Texas, 75390, United States
Duramed Investigational Site
Houston, Texas, 77024, United States
Duramed Investigational Site
San Antonio, Texas, 78229, United States
Duramed Investigational Site
Salt Lake City, Utah, 84102, United States
Duramed Investigational Site
Williston, Vermont, 05495, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Teva Branded Pharmaceutical Products, R&D Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Duramed Medical Monitor
Duramed Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2006
First Posted
November 1, 2006
Study Start
October 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
July 26, 2013
Results First Posted
June 19, 2013
Record last verified: 2013-07