Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

Low platelet counts can occur as a result of blood diseases like bone marrow failure, or from undergoing procedures such as chemotherapy treatment or stem cell transplantation. A major complication of low platelet counts in reproductive aged women is uterine bleeding, which can be life threatening. Sometimes this bleeding begins with a normal menstrual cycle but may start unexpectedly. In either instance, stopping uterine bleeding not only requires blood products including platelets but also hormonal treatments. The hormones estrogen or progesterone can aid in this setting presumably by promoting endometrial angiogenesis. Continuous oral contraceptive pills (OCP) have been shown to be very effective in the management of heavy menstrual bleeding in healthy women, but few studies have been carried out in women with low platelet counts. Moreover, they have few side-effects and are contraceptive. High-dose intravenous Premarin is also useful but only for a couple of days after which heavy bleeding will ensue. Progestin hormones are similarly effective and are also contraceptive. Oral contraceptive pills are routinely used to control uterine bleeding in thrombocytopenia secondary to bone marrow failure, chemotherapy and/or stem cell transplantation, during episodes of severe thrombocytopenia. There are no current data supporting whether the use of hormonal management is necessary in addition to platelet transfusion. We expect to show that using continuous OCP in addition to having platelet transfusions will result in a better and more rapid control of uterine bleeding than having platelet transfusions only. Eligible subjects will be hemodynamically stable, menstruating women aged 12-55, who have bone marrow failure, or are undergoing chemotherapy and/or stem cell transplantation for other diseases with platelet levels less than 50,000 microliters and present with heavy menstrual bleeding which is expected to last at least 2 weeks. Subjects will be randomized to either continuous OCP (Lo-ovral) 1 tablet twice daily or placebo twice daily for one week. All subjects will receive platelet transfusions to keep platelet levels above 20,000 microliters throughout the study. After one week, all subjects who continue to bleed will receive continuous OCP 1 tablet twice daily. Those who have stopped bleeding will receive continuous OCP 1 tablet daily. Treatments will be compared for the proportion who stop vaginal bleeding 7 and 14 days after starting treatment.


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 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


Study is Available At:


Original ID:

080022


NCT ID:

NCT00556400


Secondary ID:

08-CH-0022


Study Acronym:


Brief Title:

Treatment of Menorrhagia in Women With Thrombocytopenia: Comparison of Platelet Transfusion Alone to Platelet Transfusion With Continuous Oral Contrac


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Female


Minimum Age:

12 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

1


Enrollment Type:

Actual


Overall Contact Information

Official Name:Margaret F Bevans, Ph.D.
Principal Investigator
National Institutes of Health Clinical Center (CC)

Study Dates

Start Date:November 2007
Completion Date:June 2012
Completion Type:Actual
Primary Completion Date:June 2012
Primary Completion Type:Actual
Verification Date:June 2012
Last Changed Date:December 8, 2012
First Received Date:November 9, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Proportion who stop uterine bleeding by day 14. Total number of bleeding days during the first 7 days. Number of days after starting treatment until bleeding stops or spotting. Amount of unterine bleeding. Total number units of PRBC and platelet...
Time Frame:2 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Stop vaginal bleeding or spotting.
Time Frame:1 week
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Lo-Ovral Oral Contraceptive Pills
Description:N/A

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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. 2004 Aug;34(4):363-6.
PMID:15195079
Reference Type:Reference
Citation:Girling JE, Rogers PA. Recent advances in endometrial angiogenesis research. Angiogenesis. 2005;8(2):89-99. Epub 2005 Oct 7. Review.
PMID:16211359
Reference Type:Reference
Citation: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. 2007 Mar;22(3):635-43. Epub 2007 Jan 4.
PMID:17204526

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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