Phase 3
N=451
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
Uterine Fibroids
Bottom Line
View on ClinicalTrials.gov: NCT01629563 ↗Enrolled (actual)
451
Serious AEs
6.2%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses — 48.7; 60.5 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PGL4001 5 mg (Drug); PGL4001 10 mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- PregLem SA
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses |
48.7; 60.5 | — |
| SECONDARY Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4 |
69.6; 74.5 | — |
| SECONDARY Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses |
67.1; 71.9 | — |
| SECONDARY Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids |
-67.0; -70.4 | — |
| SECONDARY Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL) |
-31.25; -28.13 | — |
| SECONDARY Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL) |
20.69; 15.52 | — |
| SECONDARY Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS) |
-20.0; -23.0 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01629563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.