A Phase 3 interventional study of PGL4001 (ulipristal) and iron and PGL4001 matching placebo and iron in Uterine Myomas, sponsored by PregLem SA. Completed at 38 sites in 6 countries. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-12-13.
Sponsored by PregLem SA · Phase 3, Interventional, and Treatment
This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
61 studies on the registry are indexed under Myoma; 10 are open to participants now.
This study's enrollment of 241 is above the median of 80 across 45 interventional studies indexed under Myoma.
Browse Myoma studies →PregLem SA is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 (ulipristal) and iron
PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 (ulipristal) and iron
PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+
Drug: PGL4001 matching placebo and iron
Drug page: Ulipristal
tablets
Also known as: Ulipristal acetate
tablets
Also known as: Placebo of ulipristal
Drug page: Ulipristal
Tablets
Also known as: Ulipristal acetate
Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)
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: Week 13 visit
Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)
Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.
Time frame: Week 13
| Milestone | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) |
|---|---|---|---|
| Started | 95 | 98 | 48 |
| Completed | 89 | 90 | 45 |
| Not completed | 6 | 8 | 3 |
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.
| percentage of patients | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) |
|---|---|---|---|
| Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) | 91.5 | 92.5 | 18.8 |
Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes.
| percentage of change | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) |
|---|---|---|---|
| Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) | -21.2 (-100 to 223.4) | -12.3 (-100 to 146.6) | 3 (-100 to 134.8) |
Collected over 3 years 2 months. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A (PGL4001 5mg) | — | 2/95 (2.1%) | 47/95 (49.5%) |
| B (PGL4001 10mg) | — | 1/98 (1%) | 52/98 (53.1%) |
| C (Placebo) | — | 2/48 (4.2%) | 22/48 (45.8%) |
| Event | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) |
|---|---|---|---|
| New uterine leiomyomaReproductive system and breast disorders | 0/95 | 0/98 | 1/48 |
| breast cancerReproductive system and breast disorders | 0/95 | 0/98 | 1/48 |
| Ovarian hemorrhageReproductive system and breast disorders | 1/95 | 0/98 | 0/48 |
| Uterine hemorrhageReproductive system and breast disorders | 1/95 | 1/98 | 0/48 |
| Event | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) |
|---|---|---|---|
| Reproductive system and breast disordersReproductive system and breast disorders | 14/95 | 14/98 | 6/48 |
| Infections and infestationsInfections and infestations | 8/95 | 12/98 | 3/48 |
| Nervous system disordersNervous system disorders | 4/95 | 11/98 | 3/48 |
| HeadacheNervous system disorders | 4/95 | 10/98 | 2/48 |
| Gastrointestinal disordersGastrointestinal disorders | 9/95 | 10/98 | 3/48 |
| Endocrine disordersEndocrine disorders | 5/95 | 8/98 | 1/48 |
| Metabolism and nutrition disordersMetabolism and nutrition disorders | 7/95 | 4/98 | 2/48 |
| Breat pain / tenderness / disconfortReproductive system and breast disorders | 2/95 | 6/98 | 0/48 |
| General disorders and administration site conditionsGeneral disorders | 5/95 | 4/98 | 2/48 |
| ConstipationGastrointestinal disorders | 4/95 | 0/98 | 1/48 |
| Age, Categorical(Participants) | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 95 | 98 | 48 | 241 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age Continuous(years) | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) | Total |
|---|---|---|---|---|
| Mean | 41.2 ± 5.9 | 42.0 ± 5.5 | 41.6 ± 5.6 | 41.6 ± 5.7 |
| Sex: Female, Male(Participants) | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) | Total |
|---|---|---|---|---|
| Female | 95 | 98 | 48 | 241 |
| Male | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | A (PGL4001 5mg) | B (PGL4001 10mg) | C (Placebo) | Total |
|---|---|---|---|---|
| Czech Republic | 7 | 6 | 3 | 16 |
| Hungary | 7 | 11 | 9 | 27 |
| India | 10 | 11 | 7 | 28 |
| Romania | 17 | 17 | 8 | 42 |
| Russian Federation | 28 | 19 | 13 | 60 |
| Ukraine | 26 | 34 | 8 | 68 |
The record gives a start of Oct 2008, a primary completion of Mar 2010 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2012, 2 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ulipristal
PregLem SA