A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale.

Condition(s) targeted: Breakthrough Bleeding

Intervention: DR-1031a (Drug); DR-1031b (Drug); DR-1031c (Drug); Seasonale (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Duramed Research

Official(s) and/or principal investigator(s):
Duramed Medical Monitor, Principal Investigator, Affiliation: Duramed Research

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

Official title: 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

Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Total number of bleeding and/or spotting days during active treatment period.

Secondary outcome:

Total number of bleeding days during active treatment period

Timing and severity of bleeding

Onset,duration,severity of scheduled withdrawal bleeding

Number of subjects reporting hormone-related symptoms

Adverse events reported by subjects and investigators

Detailed description: 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 days after completion of study drug.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

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, Vista, California 92083, United States

Duramed Investigational Site, San Francisco, California 94102, United States

Duramed Investigational Site, San Diego, California 92108, United States

Duramed Investigational Site, Santa Ana, California 92705, United States

Duramed Investigational Site, Pueblo, Colorado 81001, United States

Duramed Investigational Site, Stratford, Connecticut 06615, United States

Duramed Investigational Site, West Palm Beach, Florida 33401, United States

Duramed Investigational Site, Miami, Florida 33186, 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, West Palm Beach, Florida 33407, United States

Duramed Investigational Site, Tampa, Florida 33607, United States

Duramed Investigational Site, Douglasville, Georgia 30134, United States

Duramed Investigational Site, Savannah, Georgia 31406, United States

Duramed Investigational Site, Alpharetta, Georgia 30005, United States

Duramed Investigational Site, Meridian, Idaho 83642, United States

Duramed Investigational Site, Boise, Idaho 83712, United States

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Duramed Investigational Site, Wichita, Kansas 67205, United States

Duramed Investigational Site, Baton Rouge, Louisiana 70808, United States

Duramed Investigational Site, Shreveport, Louisiana 71106, United States

Duramed Investigational Site, Metairie, Louisiana 70006, 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 89128, United States

Duramed Investigational Site, N. Las Vegas, Nevada 89030, United States

Duramed Investigational Site, Las Vegas, Nevada 89109, United States

Duramed Investigational Site, Lebanon, New Hampshire 03756, United States

Duramed Investigational Site, Winston-Salem, North Carolina 27103, United States

Duramed Investigational Site, New Bern, North Carolina 28562, United States

Duramed Investigational Site, Cary, North Carolina 27511, United States

Duramed Investigational Site, Cleveland, Ohio 44122, United States

Duramed Investigational Site, Mayfield Heights, Ohio 44124, United States

Duramed Investigational Site, Medford, Oregon 97504, United States

Duramed Investigational Site, Eugene, Oregon 97401, United States

Duramed Investigational Site, Pittsburgh, Pennsylvania 15206, United States

Duramed Investigational Site, Columbia, South Carolina 29201, United States

Duramed Investigational Site, Charleston, South Carolina 29425, United States

Duramed Investigational Site, Hilton Head Island, South Carolina 29926, United States

Duramed Investigational Site, Jackson, Tennessee 38305, United States

Duramed Investigational Site, San Antonio, Texas 78229, United States

Duramed Investigational Site, Houston, Texas 77024, United States

Duramed Investigational Site, Austin, Texas 78737, United States

Duramed Investigational Site, Dallas, Texas 75390, United States

Duramed Investigational Site, Salt Lake City, Utah 84102, United States

Duramed Investigational Site, Williston, Vermont 05495, United States

Starting date: October 2006
Ending date: February 2008
Last updated: February 18, 2008