Clinical trial · Interventional
Efficacy and Safety Study of Ulipristal Acetate in Females With Anemia Associated With Uterine Leiomyoma
A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas
NCT01553123CI-TRIAL-00009341withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyomas | Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iron | Drug | — | UNRESOLVED |
| Ulipristal Acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ulipristal with iron
- interventionNames
- Drug: Ulipristal Acetate
- Drug: Iron
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo with iron
- interventionNames
- Drug: Iron
Primary outcomes (1)
- measure
- Change from baseline in hemoglobin levels (g/dL)
- timeFrame
- Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
- description
- Change from baseline in hemoglobin levels (g/dL)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Is a pre-menopausal female, 18 - 50 years; * Has documented leiomyoma(s); * Has leiomyoma-related anemia; * Has an endometrial biopsy within the screening period prior to the first dose of the test article which shows no endometrial hyperplasia; * Is willing and able to provide written informed consent and authorization to disclose protected health information. Exclusion Criteria: * Has a history of uterine surgery that would interfere with the study; * Has a condition requiring immediate or intermittent blood transfusions; * Has a known coagulation disorder; * Has a history of uterine, cervix, ovarian, or breast cancer; * Has used a selective progesterone receptor modulator or a gonadotrophin releasing hormone agonist in previous 6 months; * Has received blood transfusion within 8 weeks before the screening visit; * Has abnormal liver functions; * Is pregnant.
References
Publications (0)
Data not yet available
No reference posted for this study.