Status:
WITHDRAWN
CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Urogenital Abnormalities
Eligibility:
All Genders
25-50 years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
Abnormal uterine bleeding is the most common gynecologic complaint in reproductive aged women. Medical treatment of abnormal uterine bleeding has high failure rates and surgical management remains the...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01493791
Start Date
November 8 2011
End Date
July 24 2013
Last Update
December 17 2019
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