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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Contrace

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

Detailed 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 days after completion of study drug.


Sponsor: Duramed Research

Current Primary Outcome:

  • Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]
    Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.
  • Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ]
    Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection.


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

Current Secondary Outcome:

  • Days With Bleeding During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]
    Bleeding is defined as a flow heavy enough to require sanitary protection.
  • Days With Bleeding During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ]
    Bleeding is defined as a flow heavy enough to require sanitary protection.
  • Time to First Bleeding Day [ Time Frame: Day 1-84 ]

    Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection.

    Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding.

  • Maximum Bleeding Severity During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]

    Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy.

    Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity.

    See pre-specified analyses for Number of Moderate to Heavy Bleeding Days.

  • Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91) [ Time Frame: Day 85-91 ]
    Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1.
  • Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183) [ Time Frame: Day 177-183 ]
    Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2.
  • Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84) [ Time Frame: Day 1-84 ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
  • Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176) [ Time Frame: Day 92-176 ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
  • Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 1 (Day 85-91) [ Time Frame: Day 85-91 ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.
  • Participants Reporting Hormone-Related Symptoms During the 7-day Withdrawal Cycle 2 (Day 177-183) [ Time Frame: Day 177-183 ]
    Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability.


Original 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


Information By: Teva Pharmaceutical Industries

Dates:
Date Received: October 30, 2006
Date Started: October 2006
Date Completion:
Last Updated: July 12, 2013
Last Verified: July 2013