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

NCT00556400 | Terminated Phase 1 Results

• 2 other identifiers: 08002208-CH-0022
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Aplastic Anemia; Menorrhagia; Amenorrhea

Keywords

Uterine Bleeding; Thrombocytopenia; Aplastic Anemia; Oral Contraceptive Pills; Menorrhagia

Outcome Measures

Primary Outcomes (1)

• Stop Vaginal Bleeding or Spotting.

  1 week

Secondary Outcomes (2)

• Proportion Who Stop Uterine Bleeding by Day 14.

  2 weeks

• Total Number of Bleeding Days During the First 7 Days.

  1 week

Study Arms (2)

Lo-ovral

ACTIVE COMPARATOR

1 tablet of lo-ovral is administered twice a day

Drug: Lo-Ovral Oral Contraceptive Pills

sugar pill

PLACEBO COMPARATOR

Sugar pill was provided as a placebo

Drug: Placebo - sugar pill

Interventions

Lo-Ovral Oral Contraceptive Pills DRUG

Lo-ovral

Placebo - sugar pill DRUG

sugar pill

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

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

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1038/sj.bmt.1704577.

  PMID: 15195079 BACKGROUND

• Girling JE, Rogers PA. Recent advances in endometrial angiogenesis research. Angiogenesis. 2005;8(2):89-99. doi: 10.1007/s10456-005-9006-9. Epub 2005 Oct 7.

  PMID: 16211359 BACKGROUND

• 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. doi: 10.1093/humrep/del478. Epub 2007 Jan 4.

  PMID: 17204526 BACKGROUND

MeSH Terms

Conditions

Anemia, Aplastic; Menorrhagia; Amenorrhea; Uterine Hemorrhage; Thrombocytopenia

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Failure Disorders; Bone Marrow Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Blood Platelet Disorders; Cytopenia

Limitations and Caveats

Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.

Results Point of Contact

• Title: Dr. Pamela Stratton
• Organization: NICHD

strattop@mail.nih.gov

301 496-9079

Study Officials

• Pamela Stratton, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 19, 2013
• Results First Posted: July 11, 2013

Record last verified: 2013-07

Locations

US (1)