Clinical Trial: Safety Study of XP12B in Women With Menorrhagia

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

Official Title: Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia

Brief Summary: The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Detailed Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome:

  • Number of Subjects With at Least One Adverse Event During the Study [ Time Frame: Up to 27 menstrual cycles ]
    An adverse event is any untoward, undesired, unplanned clinical event in the form of signs. symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor study drug, regardless of causal relationship.
  • Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study [ Time Frame: Up to 27 menstrual cycles ]
    The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A possibly treatment-related adverse event is an event that may be explained by administration of the study drug or by the subjects's clinical state or other agents/therapies.
  • Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study [ Time Frame: Up to 27 menstrual cycles ]
    The causal relation between an adverse event and the study drug was determined by the investigator on the basis of his or her clinical judgment. A probably treatment-related adverse event is an event most likely to be explained by administration of the study drug rather than the subjects's clinical state or other agents/therapies.
  • Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study [ Time Frame: Up to 27 menstrual cycles ]
    The causal relation between an adverse event and the study drug was determined by the

    Original Primary Outcome: Safety through 12 months

    Current Secondary Outcome:

    Original Secondary Outcome: Quality of life through 12 months

    Information By: Ferring Pharmaceuticals

    Dates:
    Date Received: June 8, 2005
    Date Started: June 2005
    Date Completion:
    Last Updated: June 9, 2010
    Last Verified: June 2010