PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIV)

PregLem

Status and phase: Completed; Phase 3

Conditions: Uterine Fibroids

Treatments: Drug: PGL4001 5 mg; Drug: PGL4001 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629563

PGL11-006

Details and patient eligibility

About

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.

Full description

The target population is composed of pre-menopausal women with symptomatic uterine myoma(s) characterised by heavy bleeding.The main objective of this study is to assess the sustained efficacy and safety of long term on-off treatment with PGL4001 5 or 10mg doses on uterine bleeding, myoma size, pain and quality of life.

Enrollment: 451 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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451 participants in 2 patient groups

Ulipristal acetate (PGL4001) 5mg

Experimental group

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.

Treatment:

Drug: PGL4001 5 mg

Ulipristal acetate (PGL4001) 10mg

Experimental group

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.

Treatment:

Drug: PGL4001 10 mg