CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women

• Status: Withdrawn
• Trial end date: 2013-07-24
• Target enrollment: 0
• Participant gender: All

Summary

Background:

• CDB-2914 is a hormone that blocks progesterone, which is necessary for maintaining pregnancy. In women with fibroid tumors, CDB-2914 shrank the tumors. In many cases, menstrual periods stopped during treatment. Because CDB-2914 decreased or stopped menstrual bleeding in women with fibroids, it may be able to treat abnormal periods in women without fibroids.

Objectives:

• To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women.

Eligibility:

• Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids.

Design:

• Participants will be screened with a physical exam and medical history. They will also have blood and urine tests. An ultrasound with fluid of the uterus will test for fibroids. Uterine cells will be collected for biopsy.

• For the next three menstrual cycles, participants will take either CDB-2914 or a placebo. Treatment will be studied with blood tests and symptom diaries.

• At the end of the treatment, participants have three options. They can have surgery at the Clinical Center or have another 3 months of CDB-2914. The third option is to stop treatment at the Clinical Center.

• Surgery will be either uterine ablation or hysterectomy. Only women older than age 33 may have a hysterectomy. Blood and urine samples will be collected after surgery.

• Both surgery and further treatment participants will have followup exams.

• All participants will have a final followup exam 1 year after stopping treatment....

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Ulipristal acetate

Criteria

• INCLUSION CRITERIA:

• Female gender - to evaluate effects in the target population for clinical trials

• History of abnormal uterine bleeding documented by menorrhagia impact questionnaire (MIQ) and menstrual calendar

• Anovulatory and ovulatory women will be included

• In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the counter drugs is acceptable but must be recorded.

• Ovulatory women will be defined as those who have menstrual cycles of 24 35 days and a progesterone value > 3.0 pg/mL between 5 and 9 days after in-home documentation of an LH surge

• Anovulatory women will be defined as those without an in-house LH surge in whom progesterone values 3 and 4 weeks after menses are < 3.0 ng/mL

• Hemoglobin > 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts

• Willing and able to comply with study requirements

• Age 25-40

• Using mechanical (condoms, diaphragms), sterilization or abstinence methods of contraception for the duration of the study

• Negative urine pregnancy test

• BMI less than or equal to 33, if a surgical candidate or less than or equal to 35, if not a surgical candidate.

• Creatinine less than 1.3 mg/dL

• Liver function tests within 130 percent of upper limit

• Women who elect surgery must state that they do not desire further fertility.

• Endometrial biopsy without endometrial hyperplasia or neoplasia

• Normal cervical cytology screening within the last 12 months

EXCLUSION CRITERIA:

• Significant abnormalities in the history, physical or laboratory examination

• Pregnancy

• Lactation

• Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year

• History of malignancy within the past 5 years

• Vaginal Bleeding in context of anatomic abnormality, endometrial neoplasia or hyperplasia, cervical, vaginal, or vulvar neoplaisa or preneoplastic pathology

• Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations

• Current use of agents known to induce hepatic P450 enzymes; use of imidazoles

• Current use of GnRH analogs or other compounds that affect menstrual cyclicity

• Use of herbal medication having estrogenic or antiestrogenic effects within the past 3 months

• FSH > 20 IU/mL

• Untreated cervical dysplasia

• Need for interval use of narcotics

• Abnormal adnexal/ovarian mass

• Contradiction to anesthesia, for women planning surgery

• Leiomyomata, polyps or other anatomic causes of vaginal bleeding

• Previous participation in the study

• Thrombocytopenia defined as platelets < 150,000

• Patients with known abnormal breast pathology