Clinical trialNCT01493791WithdrawnEarly phase 1Interventional

CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women

SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Enrollment0Urogenital Abnormalities

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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....

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alicia Y Christy, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator
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Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

CDB-2914

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 8 Nov 2011
Primary completion: 24 Jul 2013
Completion: 24 Jul 2013
Last update posted: 17 Dec 2019
Registered enrollment: 0
Registry id: NCT01493791

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.