Protocol Number: 08-CH-0022

Title:

Treatment of Menorrhagia in Women with Aplastic Anemia: Platelet Transfusion Alone to Platelet Transfusion with Continuous Oral Contraceptive Pills

Number:

08-CH-0022

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/microl) 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/microl. 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.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria:

INCLUSION CRITERIA:

Women aged 12-55 years who have a uterus and at least one functioning ovary.

Women with any active uterine bleeding more than spotting

Diagnosed with aplastic anemia with platelet counts less than 50,000 microliters at study entry

Do not desire pregnancy for the duration of the study.

Willing and able to give informed consent.

Willing and able to comply with study requirements.

EXCLUSION CRITERIA:

Age less than 12 years

Postmenopausal women

Hormone level in menopausal range: FSH 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 DMPA injections in the past 12 months or having DMPA 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

Special Instructions:

Currently Not Provided

Keywords:

Uterine Bleeding

Thrombocytopenia

Aplastic Anemia

Oral Contraceptive Pills

Menorrhagia

Recruitment Keyword(s):

Aplastic Anemia

Uterine Bleeding

Menorrhagia

Condition(s):

Aplastic Anemia

Menorrhagia

Amenorrhea

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Lo-Ovral Oral Contraceptive Pills

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Amsterdam A, Jakubowski A, Castro-Malaspina H, Baxi E, Kauff N, Krychman M, Stier E, Castiel M. Treatment of menorrhagia in women undergoing hematopoietic stem cell transplantation. Bone Marrow Transplant, 34: 363-366.

Girling JE, Rogers PA. Recent advances in endometrial angiogenesis research. Angiogenesis, 8: 89-99.

Fraser IS, Critchley HO, Munro MG, Broder M. Can we achieve international agreement on terminologies and definitions used to describe abnormalities of menstrual bleeding? Hum Reprod, 22: 635-643.

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