Clinical trial · Interventional
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids
NCT01629563CI-TRIAL-00040412PEARLIVcompletedPhase 3Results postedClinicalTrials.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)
Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.
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 10 mg | Drug | — | UNRESOLVED |
| PGL4001 5 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ulipristal acetate (PGL4001) 5mg
- description
- All subjects will be asked to take a 150mg size tablet (PGL4001 5mg or matching placebo: placebo 5) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 150mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
- interventionNames
- Drug: PGL4001 5 mg
- type
- EXPERIMENTAL
- label
- Ulipristal acetate (PGL4001) 10mg
- description
- All subjects will be asked to take a 300mg size tablet (PGL4001 10mg or matching placebo: placebo 10 ) orally daily for repeated periods 84 days. The first treatment course will start on the first 4 days of menstruation and will be orally administered, once daily (1 tablet of 300mg size), for 84 days. The following three treatment courses should be started in the first two days of a menstrual period.
- interventionNames
- Drug: PGL4001 10 mg
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Be a pre-menopausal woman between 18 and 50 years inclusive. * Have a Body Mass Index (BMI) ≥ 18 and ≤ 40. * Have FSH levels ≤ 20 mIU/mL * Have excessive uterine bleeding due to myoma. * Have regular menstrual cycles * Have a myomatous uterus \< 16 weeks with at least one myoma ≥ 3 cm in diameter. * If of childbearing potential the subject must be practicing a non-hormonal method of contraception. Exclusion Criteria: * Has a history of or current uterine, cervical, ovarian or breast cancer. * Has a history of or current endometrium atypical hyperplasia or adenocarcinoma. * Has a known severe coagulation disorder. * Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM). * Has abnormal hepatic function at study entry. * Has a positive pregnancy test, is nursing or planning a pregnancy during the course of the study. * Has a current (within twelve months) problem with alcohol or drug abuse. * Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
References
Publications (2)
- DERIVEDDonnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23. PMID 26477496
- DERIVEDDonnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24. PMID 25542821