PGL4001 Versus GnRH-agonist in Uterine Myomas (PEARLII)
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|ClinicalTrials.gov Identifier: NCT00740831|
Recruitment Status : Completed
First Posted : August 25, 2008
Results First Posted : November 16, 2012
Last Update Posted : December 17, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Uterine Myomas||Drug: PGL4001 Drug: leuprorelin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||301 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||June 2010|
Experimental: A (PGL4001 5 mg)
Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Other Name: Ulipristal acetate
Experimental: B (PGL4001 10mg)
Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Other Name: Ulipristal acetate
Active Comparator: C (GnRH-agonist)
PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
solution for injection
Other Name: GnRH-agonist
- Percentage of Subjects With Reduction of Uterine Bleeding at Week 13 Visit Defined as Pictorial Blood-loss Assessment Chart (PBAC) Score < 75 at End-of-treatment Visit (Week 13 Visit) [ Time Frame: 3 months ]
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.
Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.
A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.
Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.
The week 13 PBAC score was calculated using the last 28 days of treatment.
- Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist [ Time Frame: Week 13 visit ]Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples
- Co-primary Safety Endpoint: % of Subjects Reporting Moderate or Severe Hot Flushes as Adverse Events Throughout the Treatment Period for PGL4001 Compared With GnRH-agonist [ Time Frame: Up to week 17 ]
Difference in percentage of subjects reporting moderate or severe hot flushes:
Frequency and severity of this adverse event(as spontaneously reported by patients or elicited by nonleading questions) were recorded on standard forms at every visit up to week 17.
- Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 [ Time Frame: 3 months ]
Assessment of PGL4001 capacity to decrease volume of the three largest myomas was performed at each center by means of ultrasonography at baseline and at week 13.
The total volume of the three largest myomas assessed at screening and at end-of-treatment visit (Week 13) was analysed on a logarithm transformed scale (to base 10).
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Be a pre-menopausal woman between 18 and 50 years inclusive.
- Have excessive uterine bleeding due to myoma
- Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
- Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
- If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
- Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.
- 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) or a GnRH-agonist.
- Has a history of or known current osteoporosis.
- Has abnormal hepatic function at study entry.
- Has a positive pregnancy test at baseline or 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740831
|Study Director:||Dr Elke Bestel||PregLem SA|
|Responsible Party:||PregLem SA|
|Other Study ID Numbers:||
|First Posted:||August 25, 2008 Key Record Dates|
|Results First Posted:||November 16, 2012|
|Last Update Posted:||December 17, 2012|
|Last Verified:||December 2012|
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