Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Aplastic Anemia, Menorrhagia, Amenorrhea
In brief
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.
Key facts
- Study ID
- NCT00556400
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 1
- Starts
- 2007-11-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2013-07-19
Who can join
Age: 12 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- Age less than 12 years
- Postmenopausal women
- Hormone level in menopausal range: Follicle Stimulating Hormone greater than 40 IU/L, E (2) less than 20 pg/ml
- History of liver disease that precludes OCP use
- History of thrombosis, thromboembolism and/or thrombophilia.
- Currently on 2 or more tablets of any oral contraceptive pills per day at study entry
- Having 2 or more depo medroxyprogesterone acetate injections in the past 12 months or having depo medroxyprogesterone acetate injection in the past 90 days
- Leuprolide acetate injection in the past 30 days
- Smoker over the age of 35
- Women with estrogen dependent tumor e.g. breast cancer.
- Pregnancy.
- Underlying sickle cell anemia
- Women who are taking chemotherapeutic agents known to cause ovarian failure such as alkylating agents
- Allergy to any medication in this protocol
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.