Uterine Fibroids
Conditions
Brief summary
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.
Detailed description
PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.
Interventions
DRUGPGL4001, placebo
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
DRUGPGL4001, progestin
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).
Sponsors
PregLem SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoints | From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo. | Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire). |
| Number and proportion of subjects experiencing open label treatment-emergent adverse events | From baseline to end of PGL4001 treatment (3months treatment) | — |
Countries
Austria, Belgium, Poland, Spain
Outcome results
None listed