PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata

Browse trials for

• Leiomyoma 490
• Myofibroma 344

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's enrollment of 451 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Lead sponsor

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

Study arms

• Experimental
  Ulipristal acetate (PGL4001) 5mg

  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.

  Drug: PGL4001 5 mg

• Experimental
  Ulipristal acetate (PGL4001) 10mg

  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.

  Drug: PGL4001 10 mg

Interventions

• DrugPGL4001 5 mg

  PGL4001 5 mg daily administration

  Also known as: Ulipristal Acetate, Esmya

• DrugPGL4001 10 mg

  PGL4001 10mg daily administration

  Also known as: Ulipristal Acetate

Primary outcomes

1. Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses

   Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.

   Time frame: 18 months study duration per subject (4 3-month intermittent treatment courses)

Secondary outcomes

1. Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4

   Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.

   Time frame: After 18 months

2. Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses

   Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course. Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days.

   Time frame: After 18 months

3. Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids

   For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6). Subjects were exposed to 4 3-month intermittent courses.

   Time frame: After 18 months

4. Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)

   Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100). Subjects were exposed to 4 3-month intermittent courses.

   Time frame: After 18 months

5. Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)

   Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life. Subjects were exposed to 4 3-month intermittent courses.

   Time frame: 18 months

6. Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)

   Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain. Subjects were exposed to 4 3-month intermittent courses.

   Time frame: After 18 months

Baseline characteristics

Publications

• Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23. PubMed 26477496 ↗
• Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24. PubMed 25542821 ↗