Protocol Details

Treatment of Menorrhagia in Women with Thrombocytopenia: Comparison of Platelet Transfusion Alone to Platelet Transfusion with Continuous Oral Contraceptive Pills

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	08-CH-0022
Sponsoring Institute	National Institute of Child Health and Human Development (NICHD)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Female Min Age: 12 Max Age: 55
Referral Letter Required	No
Population Exclusion(s)	Male
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

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.

--Back to Top--

Eligibility

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 bone marrow failure, and other disease that require treatment with chemotherapy or stem cell transplantation 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

--Back to Top--

Citations:

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.

--Back to Top--

Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Pamela Stratton, M.D. National Institute of Child Health and Human Development (NICHD) National Institutes of Health Building 12A Room 2003 12 South Drive Bethesda, Maryland 20892 (301) 435-9235 amir@helix.nih.gov	Vien H. Vanderhoof, C.R.N.P. National Institute of Child Health and Human Development (NICHD) Building 9, Room B1E05 9 Memorial Drive Bethesda, MD 20892 (301) 594-0352 kainersj@mail.nih.gov	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 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00556400

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

• Details on how to participate in a study
• Details on how to refer a patient to a study

NIH Clinical Studies Information Request

---

Contact the Office of Communications for:

• General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml

---

Contact the Department Clinical Research Informatics, (DCRI) for:

• Technical questions about Adobe Acrobat and the PDF format
• Technical questions about this web server

webmaster@cc.nih.gov