Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones

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Brief Title

Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones

Official Title

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

Brief 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.
    

Detailed Description

      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/ microliter 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 per
      microliter 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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Stop Vaginal Bleeding or Spotting.

Secondary Outcome

 Proportion Who Stop Uterine Bleeding by Day 14.

Condition

Aplastic Anemia

Intervention

Lo-Ovral Oral Contraceptive Pills

Study Arms / Comparison Groups

 Lo-ovral
Description:  1 tablet of lo-ovral is administered twice a day

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1

Start Date

November 2007

Completion Date

June 2012

Primary Completion Date

June 2012

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 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: 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
      

Gender

Female

Ages

12 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Pamela Stratton, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00556400

Organization ID

080022

Secondary IDs

08-CH-0022

Responsible Party

Sponsor

Study Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Study Sponsor

Pamela Stratton, MD, Principal Investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)


Verification Date

July 2013