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NCT01493791
CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women
EARLY_PHASE1 trial testing CDB-2914 in Urogenital Abnormalities. Withdrawn.
24 July 2013
Quick facts
| Lead sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Primary purpose | treatment |
| Start date | 8 November 2011 |
| Primary completion | 24 July 2013 |
| Estimated completion | 24 July 2013 |
Drugs / interventions tested
- CDB-2914 — full drug profile →
Conditions studied
- Urogenital Abnormalities — all drugs for Urogenital Abnormalities →
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Who can join
Adults 25 to 50, any sex, with Urogenital Abnormalities. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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....
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of CDB-2914
Trials testing the same drug.
- NCT00044876 — Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist · Phase 2 · completed
Other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trials
Trials by the same sponsor.
- NCT07502586 — Turner Syndrome: Genetic Considerations · recruiting
- NCT07357701 — Identifying Genome Variants in Non-Obstructive Azoospermia (NOA) or Primary Ovarian Insufficiency (POI) · recruiting
- NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
- NCT05548881 — Implications of Maternal 45,X Mosaicism as a Secondary Genomic Finding Following Cell-Free DNA Sequencing During Pregnan · withdrawn
- NCT06749366 — Uncovering Genes Behind Cartilage Tumors and Vascular Anomalies Using Genomic Sequencing · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01493791 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Last refreshed: 17 December 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01493791.
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