Phase 3 N=784 Treatment

Safety Study of XP12B in Women With Menorrhagia

Menorrhagia · Heavy Menstrual Bleeding

Bottom Line

View on ClinicalTrials.gov: NCT00113568 ↗

Enrolled (actual)

784

Serious AEs

3.9%

Results posted

Jan 2010

Primary outcome: Primary: Number of Subjects With at Least One Adverse Event During the Study — 678 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Tranexamic acid tablets (XP12B) (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Ferring Pharmaceuticals
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With at Least One Adverse Event During the Study	678	—
PRIMARY Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study	306	—
PRIMARY Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study	40	—
PRIMARY Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study	13	—
PRIMARY Number of Subjects With at Least One Serious Adverse Event During the Study	28	—
PRIMARY Number of Subjects With at Least One Life-Threatening Adverse Event During the Study	2	—
PRIMARY Number of Subjects With Adverse Events That Led to Discontinuation From the Study	97	—
PRIMARY Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study	—	—
PRIMARY Number of Subjects Who Died During the Study	1	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Women with menorrhagia
18-49 years of age
Regularly occuring menstrual periods

Exclusion Criteria

History or presence of clinically significant disease or abnormalities that might confound the study
History of bilateral oophorectomy or hysterectomy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00113568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.