Treatment and Management of Women With Bleeding Disorders

What Was Tested

In this not phased trial, researchers set out to test Desmopressin.

The registry classes the interventions as drug.

More on the Plan

Menorrhagia is a common clinical problem.

Morbid events include dysmenorrhea, hospitalizations, red blood cell transfusions, and quality of life impairment in terms of daily activities, chronic pain, and time lost from work and or school.

Intuitively, the prevalence of vWd in women with menorrhagia is probably higher since platelet plug formation is necessary for menstrual hemostasis.

Current management of menorrhagia in patients in the United States often begins with hormonal therapy.

Who Took Part

100 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Referred to study by gynecologist or internist/family practitioner with diagnosis of menorrhagia or referred by self through community advertising or networking. Prospective pictorial chart scores of menses \>100. Periods at least every 39 days.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: patient is not proficient in english; patient is pregnant; patient on hormone replacement, depo-provera, or norplant in last three months.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Desmopressin and the comparison at some point, usually with a gap in between.

Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2001-01 with completion listed for 2006-09.

It ran at 6 sites in United States (6).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Changes in quality of life.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 100 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.