Clinical Trial: Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

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

Official Title: A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Ta

Brief Summary: To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days [ Time Frame: 90 day baseline period and 90 days during treatment period ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of subjects with successful treatment [ Time Frame: 90 days during treatment phase ]
    Successful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value </=50% of MBL compared to 90 day run-in period
  • Percent change of MBL at baseline and 90 day period during treatment phase [ Time Frame: Baseline and 90 days during treatment phase ]
  • Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days) [ Time Frame: Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7 ]
  • Proportion of subjects with improvement in the investigator's global assessment scale on Day 84 [ Time Frame: Treatment day 84 ]
    Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Proportion of subjects with improvement in the investigator's global assessment scale on Day 196 [ Time Frame: Treatment day 196 ]
    Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Proportion of subjects with improvement in the subject's global assessment scale on Day 84 [ Time Frame: Treatment day 84 ]
    Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Proportion of subjects with improvement in the subject's global assessment scale on Day 196 [ Time Frame: Treatment day 196 ]
    Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ]


Original Secondary Outcome:

  • Proportion of subjects with successful treatment [ Time Frame: 90 days during treatment phase ]
    Successful treatment is definded as no bleeding episode with MBL of 80 mL or more and a decrease to a value </=50% of MBL compared to 90 day run-in period
  • Percent change of MBL at baseline and 90 day period during treatment phase [ Time Frame: Baseline and 90 days during treatment phase ]
  • Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days) [ Time Frame: Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7 ]
  • Proportion of subjects with improvement in the investigator's global assessment scale on Day 84 [ Time Frame: Treatment day 84 ]
    Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Proportion of subjects with improvement in the investigator's global assessment scale on Day 196 [ Time Frame: Treatment day 196 ]
    Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Proportion of subjects with improvement in the subject's global assessment scale on Day 84 [ Time Frame: Treatment day 84 ]
    Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Proportion of subjects with improvement in the subject's global assessment scale on Day 196 [ Time Frame: Treatment day 196 ]
    Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ]


Information By: Bayer

Dates:
Date Received: June 20, 2012
Date Started: June 2012
Date Completion:
Last Updated: July 8, 2015
Last Verified: July 2015