Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones
Status:
Terminated
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
This study will explore the role of oral contraceptive pills in managing uterine bleeding in
women who have low blood platelet counts as a result of aplastic anemia. Oral contraceptive
pills have been shown to be effective in managing uterine bleeding in healthy women, but the
effects have not been thoroughly studied in women who have low platelet counts. The purpose
of the study is to determine whether oral contraceptive pills are a useful complement to
platelet transfusions in women with aplastic anemia and uterine bleeding.
Volunteers for this study must be women between 12 and 55 years of age who have been
diagnosed with aplastic anemia (with a platelet count of less than 50,000/microliter) and
currently have active uterine bleeding. Candidates must not be pregnant or breastfeeding,
must have a uterus and at least one functioning ovary, and must be willing to use nonhormonal
methods of birth control (such as condoms or a diaphragm) for the duration of the study. On
the first visit, candidates will be screened with a complete medical history (including
obstetric and gynecological history) and will undergo a physical examination, a pelvic exam
and a pelvic ultrasound. Blood and urine samples will also be taken on this first visit.
The study will last approximately two weeks. Participants will be asked to monitor their
medication doses and severity of bleeding during the course of the study. After the first
visit, participants will be separated into two randomized groups and will receive either one
tablet of oral contraceptive or a placebo twice daily, to be taken 12 hours apart at the same
times each day. Participants will also receive platelet transfusions as needed to ensure that
their platelet counts remain over 20,000/microliter. After seven days, researchers will
assess participants' uterine bleeding and all participants will be given oral contraceptives
in the second week of the study. Participants whose bleeding has decreased will receive only
one tablet; participants who still have moderate to severe uterine bleeding will receive two
tablets. A final assessment will be performed on day 14 of the study.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)