Menorrhagia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
| Verified date | April 2015 |
| Source | Ferring Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
| Status | Completed |
| Enrollment | 304 |
| Est. completion date | May 2008 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility |
Inclusion Criteria: - Women with menorrhagia - 18-49 years of age - Regularly occurring menstrual periods Exclusion Criteria: - History or presence of clinically significant disease or abnormalities that may confound the study - History of bilateral oophorectomy or hysterectomy - Hormone therapy for birth control |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Investigative Site | Albuquerque | New Mexico |
| United States | Investigative Site | Ann Arbor | Michigan |
| United States | Investigative Site | Atlanta | Georgia |
| United States | Investigative Site | Austin | Texas |
| United States | Investigative Site | Baltimore | Maryland |
| United States | Investigative Site | Bingham Farms | Michigan |
| United States | Investigative Site | Birmingham | Alabama |
| United States | Investigative Site | Bismarck | North Dakota |
| United States | Investigative Site | Bloomington | Indiana |
| United States | Investigative Site | Boise | Idaho |
| United States | Investigative Site | Bristol | Tennessee |
| United States | Investigative Site | Bryan | Texas |
| United States | Investigative Site | Burlington | Vermont |
| United States | Investigative Site | Clarksville | Tennessee |
| United States | Investigative Site | Cleveland | Ohio |
| United States | Investigative Site | Cleveland | Ohio |
| United States | Investigative Site | Decatur | Georgia |
| United States | Investigative Site | Denver | Colorado |
| United States | Investigative Site | Durham | North Carolina |
| United States | Investigative Site | Eugene | Oregon |
| United States | Investigative Site | Fort Worth | Texas |
| United States | Investigative Site | Gainesville | Florida |
| United States | Investigative Site | Gallipolis | Ohio |
| United States | Investigative Site | Grand Rapids | Michigan |
| United States | Investigative Site | Greenville | South Carolina |
| United States | Investigative Site | Groton | Connecticut |
| United States | Investigative Site | Houston | Texas |
| United States | Investigative Site | Idaho Falls | Idaho |
| United States | Investigative Site | Jacksonville | Florida |
| United States | Investigative Site | Kansas City | Missouri |
| United States | Investigative Site | Las Vegas | Nevada |
| United States | Investigative Site | Lawrenceville | New Jersey |
| United States | Investigative Site | Levittown | Pennsylvania |
| United States | Investigative Site | Lighthouse Point | Florida |
| United States | Investigative Site | Little Rock | Arkansas |
| United States | Investigative Site | Los Alamitos | California |
| United States | Investigative Site | Los Angeles | California |
| United States | Investigative Site | Marrero | Louisiana |
| United States | Investigative Site | McCook | Nebraska |
| United States | Investigative Site | Miami | Florida |
| United States | Investigative Site | Miami Beach | Florida |
| United States | Investigative Site | Missoula | Montana |
| United States | Investigative Site | Moorestown | New Jersey |
| United States | Investigative Site | Nashville | Tennessee |
| United States | Investigative Site | New Brunswick | New Jersey |
| United States | Investigative Site | New Port Richey | Florida |
| United States | Investigative Site | New York | New York |
| United States | Investigative Site | Newton | Kansas |
| United States | Investigative Site | Norfolk | Virginia |
| United States | Investigative Site | Oklahoma City | Oklahoma |
| United States | Investigative Site | Oklahoma City | Oklahoma |
| United States | Investigative Site | Overland Park | Kansas |
| United States | Investigative Site | Paw Paw | Michigan |
| United States | Investigative Site | Philadelphia | Pennsylvania |
| United States | Investigative Site | Philadelphia | Pennsylvania |
| United States | Investigative Site | Phoenix | Arizona |
| United States | Investigative Site | Phoenixville | Pennsylvania |
| United States | Investigative Site | Plano | Texas |
| United States | Investigative Site | Pleasant Grove | Utah |
| United States | Investigative Site | Portland | Oregon |
| United States | Investigative Site | Raleigh | North Carolina |
| United States | Investigative Site | Renton | Washington |
| United States | Investigative Site | Richmond | Virginia |
| United States | Investigative Site | Rochester | New York |
| United States | Investigative Site | Salt Lake City | Utah |
| United States | Investigative Site | San Diego | California |
| United States | Investigative Site | Sarasota | Florida |
| United States | Investigative Site | Searcy | Arkansas |
| United States | Investigative Site | Sioux Falls | South Dakota |
| United States | Investigative Site | St. Clair Shores | Michigan |
| United States | Investigative Site | Strafford | Pennsylvania |
| United States | Investigative Site | Temple | Texas |
| United States | Investigative Site | Tucson | Arizona |
| United States | Investigative Site | Tucson | Arizona |
| United States | Investigative Site | Waco | Texas |
| United States | Investigative Site | Webster | Texas |
| United States | Investigative Site | West Jordan | Utah |
| United States | Investigative Site | West Valley City | Utah |
| United States | Investigative Site | Wexford | Pennsylvania |
| United States | Investigative Site | Winston-Salem | North Carolina |
| United States | Investigative Site | Woodlands | Texas |
| United States | Investigative Site | Wynnewood | Pennsylvania |
| United States | Investigative Site | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Reduction From Baseline in Menstrual Blood Loss (MBL) | reduction of menstrual blood loss in mL | Baseline MBL over 3 menstrual cycles | No |
| Secondary | Patient Reported Outcome Measure of Limitations in Social or Leisure Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited | Baseline scores over 3 menstrual cycles | No |
| Secondary | Patient Reported Outome Measure of Limitations in Physical Activities Associated With Heavy Menstrual Bleeding | A positive unit change of the mean relects an improvement from baseline. Patient reported outcome scores had the following response categories: 1=not limited at all; 2=slightly limited; 3=moderately limited; 4=quite a bit limited; and 5=extremely limited | Baseline scores over 3 menstrual cycles | No |
| Secondary | Responder Analysis - Reduction in Large Stains | Percentage of subjects who experienced a reduction from baseline in the frequency of large stains | Baseline over 3 mentrual cycles | No |
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