PGL4001 Versus GnRH-agonist in Uterine Myomas

Browse trials for

• Myoma 61

Keywords

• Uterine Myomas

Myoma

61 studies on the registry are indexed under Myoma; 10 are open to participants now.

This study's enrollment of 301 is above the median of 80 across 45 interventional studies indexed under Myoma.

Lead sponsor

PregLem SA is the lead sponsor of 10 studies on the registry; none are open to participants now.

Study arms

• Experimental
  A (PGL4001 5 mg)

  Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

  Drug: PGL4001

• Experimental
  B (PGL4001 10mg)

  Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)

  Drug: PGL4001

• Active comparator
  C (GnRH-agonist)

  PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)

  Drug: leuprorelin

Interventions

• DrugPGL4001

  tablets

  Also known as: Ulipristal acetate

• Drugleuprorelin

  solution for injection

  Also known as: GnRH-agonist

Primary outcomes

1. 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)

   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.

   Time frame: 3 months

2. Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist

   Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples

   Time frame: Week 13 visit

3. 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

   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.

   Time frame: Up to week 17

Secondary outcomes

1. Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13

   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).

   Time frame: 3 months

Baseline characteristics

Publications

• Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180. PubMed 22296076 ↗