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