A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Launched by DURAMED RESEARCH · Oct 30, 2006
Trial Information
Current as of June 17, 2025
Completed
Keywords
ClinConnect Summary
This Phase 2, prospective, multicenter, double-blinded, randomized study is designed to evaluate and compare bleeding patterns in women using one of three different doses of DR-1031 oral contraceptive with Seasonale oral contraceptive.
Patients who meet all study entrance criteria will be randomly assigned to one of four treatment groups,
The overall study duration will be approximately 9 months; this will include a screening period of approximately 4 weeks, a run-in period of 4 weeks, a treatment period of approximately 6 months (two,91-day cycles) and a final study visit occurring 14-21...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Premenopausal
- • Not pregnant or breastfeeding
- • Agree to use back-up non-hormonal contraception for study period
- Exclusion Criteria:
- • Any contraindication to the use of oral contraceptives
- • Pregnancy within the last 3 months
- • Smoking \>10 cigarettes per day
About Duramed Research
Duramed Research is a leading clinical trial sponsor dedicated to advancing medical innovation through rigorous research and development. With a strong focus on enhancing patient outcomes, Duramed specializes in conducting phase I to phase IV clinical trials across a variety of therapeutic areas. The organization is committed to upholding the highest standards of scientific integrity and regulatory compliance, leveraging a team of experienced professionals and state-of-the-art methodologies. By fostering collaborations with healthcare providers and utilizing patient-centric approaches, Duramed Research aims to contribute significantly to the discovery and development of new therapies that address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Little Rock, Arkansas, United States
Vista, California, United States
Winston Salem, North Carolina, United States
Jackson, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Medford, Oregon, United States
Huntsville, Alabama, United States
San Diego, California, United States
Tampa, Florida, United States
Douglasville, Georgia, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Shreveport, Louisiana, United States
Las Vegas, Nevada, United States
Charleston, South Carolina, United States
Miami, Florida, United States
Alpharetta, Georgia, United States
Boise, Idaho, United States
Baton Rouge, Louisiana, United States
Cleveland, Ohio, United States
Mayfield Heights, Ohio, United States
Columbia, South Carolina, United States
Pueblo, Colorado, United States
Fort Wayne, Indiana, United States
Lebanon, New Hampshire, United States
Jacksonville, Florida, United States
Houston, Texas, United States
Williston, Vermont, United States
Tucson, Arizona, United States
San Francisco, California, United States
Santa Ana, California, United States
Stratford, Connecticut, United States
Deland, Florida, United States
Melbourne, Florida, United States
West Palm Beach, Florida, United States
Savannah, Georgia, United States
Meridian, Idaho, United States
Wichita, Kansas, United States
Metairie, Louisiana, United States
Riverdale, Maryland, United States
Kansas City, Missouri, United States
N. Las Vegas, Nevada, United States
Cary, North Carolina, United States
New Bern, North Carolina, United States
Eugene, Oregon, United States
Hilton Head Island, South Carolina, United States
Salt Lake City, Utah, United States
Patients applied
Trial Officials
Duramed Medical Monitor
Principal Investigator
Duramed Research
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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