Clinical trial · Interventional
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding.
NCT01156857CI-TRIAL-00020547PEARLIIIcompletedPhase 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)
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
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 |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PGL4001, placebo | Drug | — | UNRESOLVED |
| PGL4001, progestin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
- interventionNames
- Drug: PGL4001, placebo
- type
- EXPERIMENTAL
- label
- B
- description
- Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).
- interventionNames
- Drug: PGL4001, progestin
Primary outcomes (2)
- measure
- Efficacy endpoints
- timeFrame
- From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 48 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is a pre-menopausal woman aged between 18 and 48 years inclusive. * Subject with a Body Mass Index ≥18 and ≤40. * Subject with myomatous uterus size \< 16 weeks. * Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound. * Subject complained of strong uterine bleeding. * Subject is eligible for hysterectomy or myomectomy. * Females of childbearing potential have to practice a non-hormonal method of contraception. Exclusion Criteria: * Subject has a history of or current uterus, cervix, ovarian or breast cancer. * Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy. * Subject has a known severe coagulation disorder. * Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate. * Subject has abnormal hepatic function at study entry.
References
Publications (1)
- DERIVEDDonnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, Barlow DH, Palacios S, Donnez O, Bestel E, Osterloh I, Loumaye E; PEARL III and PEARL III Extension Study Group. Long-term treatment of uterine fibroids with ulipristal acetate ☆. Fertil Steril. 2014 Jun;101(6):1565-73.e1-18. doi: 10.1016/j.fertnstert.2014.02.008. Epub 2014 Mar 12. PMID 24630081