Clinical trial NCT00113568: Safety Study of XP12B in Women With Menorrhagia
Official title: Multicenter Study to Evaluate the Safety of XP12B in Women With Heavy Menstrual Bleeding Associated With Menorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menorrhagia
Heavy Menstrual Bleeding
Keywords: Menorrhagia
Heavy Menstrual Bleeding
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-06-09
Enrollment: 784
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Subjects With at Least One Adverse Event During the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects With at Least One Possibly Treatment-Related Adverse Event During the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects With at Least One Probably Treatment-Related Adverse Event During the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects With at Least One Definitely Treatment-Related Adverse Event During the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects With at Least One Serious Adverse Event During the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects With at Least One Life-Threatening Adverse Event During the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects With Adverse Events That Led to Discontinuation From the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects With Any Thrombotic or Thromboembolic Adverse Event During the Study
timeFrame: Up to 27 menstrual cycles
measure: Number of Subjects Who Died During the Study
timeFrame: Up to 27 menstrual cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Investigative Site
state: Alabama
city: Montgomery
country: United States
facility: Investigative Site
state: Alabama
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Phoenix
country: United States
facility: Investigative Site
state: Arizona
city: Jonesboro
country: United States
facility: Investigative Site
state: Arkansas
city: Little Rock
country: United States
facility: Investigative Site
state: Arkansas
city: San Diego
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Investigative Site
state: Colorado
city: Denver
country: United States
facility: Investigative Site
state: Colorado
city: Ft. Myers
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: New Port Richey
country: United States
facility: Investigative Site
state: Florida
city: Ocala
country: United States
facility: Investigative Site
state: Florida
city: Pinellas Park
country: United States
facility: Investigative Site
state: Florida
city: Venice
country: United States
facility: Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigative Site
state: Florida
city: Alpharetta
country: United States
facility: Investigative Site
state: Georgia
city: Roswell
country: United States
facility: Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Investigative Site
state: Georgia
city: Savannah
country: United States
facility: Investigative Site
state: Georgia
city: Boise
country: United States
facility: Investigative Site
state: Idaho
city: Champaign
country: United States
facility: Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Investigative Site
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Site
state: Indiana
city: South Bend
country: United States
facility: Investigative Site
state: Indiana
city: Overland Park
country: United States
facility: Investigative Site
state: Kansas
city: Lexington
country: United States
facility: Investigative Site
state: Kentucky
city: Louisville
country: United States
facility: Investigative Site
state: Kentucky
city: Shreveport
country: United States
facility: Investigative Site
state: Louisiana
city: Portage
country: United States
facility: Investigative Site
state: Michigan
city: Chaska
country: United States
facility: Investigative Site
state: Minnesota
city: St. Louis
country: United States
facility: Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Investigative Site
state: Missouri
city: Billings
country: United States
facility: Investigative Site
state: Montana
city: Omaha
country: United States
facility: Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: Moorestown
country: United States
facility: Investigative Site
state: New Jersey
city: Albuquerque
country: United States
facility: Investigative Site
state: New Mexico
city: Johnson City
country: United States
facility: Investigative Site
state: New York
city: Charlotte
country: United States
facility: Investigative Site
state: North Carolina
city: Durham
country: United States
facility: Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Investigative Site
state: Ohio
city: Toledo
country: United States
facility: Investigative Site
state: Ohio
city: Philadelphia
country: United States
facility: Investigative Site
state: Pennsylvania
city: Wexford
country: United States
facility: Investigative Site
state: Pennsylvania
city: Columbia
country: United States
facility: Investigative Site
state: South Carolina
city: Nashville
country: United States
facility: Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Norfolk
country: United States
facility: Investigative Site
state: Virginia
city: Seattle
country: United States
facility: Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Investigative Site
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Muse K, Lukes AS, Gersten J, Waldbaum A, Mabey RG, Trott E. Long-term evaluation of safety and health-related quality of life in women with heavy menstrual bleeding treated with oral tranexamic acid. Womens Health (Lond). 2011 Nov;7(6):699-707. doi: 10.2217/whe.11.65. Epub 2011 Aug 25.
citation: Bushnell DM, Martin ML, Moore KA, Richter HE, Rubin A, Patrick DL. Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life. Curr Med Res Opin. 2010 Dec;26(12):2745-55. doi: 10.1185/03007995.2010.532200. Epub 2010 Nov 3.