Trial · NCT00740831
PGL4001 Versus GnRH-agonist in Uterine Myomas
NCT00740831, Phase 3, Completed, PregLem SA; results first posted 2012-11-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PGL4001 Versus GnRH-agonist in Uterine Myomas. Trials, record NCT00740831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00740831
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PGL4001 Versus GnRH-agonist in Uterine Myomas
- NCT number
- NCT00740831
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 301 participants, actual
- Lead sponsor
- PregLem SA
- Conditions
- Uterine Myomas
- Interventions
- PGL4001, leuprorelin
- First posted
- 2008-08-25
- Last updated
- 2012-12-17
- Results first posted
- 2012-11-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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. |
| Primary | Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist | Week 13 visit | Measured by log 10 (log pg/ml) transformed values for estradiol (E2) in blood samples |
| Primary | 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 | 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. |
| Secondary | Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | 3 months | Per protocol | percentage of patients | NUMBER |
| SECONDARY | Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 | 3 months | Per protocol | Log 10 (Log cm3) Total volume | MEAN |
| PRIMARY | Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist | Week 13 visit | Safety population | log 10 (log pg/ml) E2 | MEAN |
| PRIMARY | 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 | Up to week 17 | Safety population | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | A (PGL4001 5mg) | 90.3 | percentage of patients | ||
| 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) | B (PGL4001 10mg) | 97.9 | percentage of patients | ||
| 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) | C (GnRH-agonist) | 89.1 | percentage of patients | ||
| Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 | A (PGL4001 5mg) | -0.179 | Standard Error 0.037 | Log 10 (Log cm3) Total volume | |
| Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 | B (PGL4001 10mg) | -0.220 | Standard Error 0.036 | Log 10 (Log cm3) Total volume | |
| Change in the Total Volume of the Three Largest Myomas From Baseline to Week 13 | C (GnRH-agonist) | -0.268 | Standard Error 0.037 | Log 10 (Log cm3) Total volume | |
| Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist | A (PGL4001 5mg) | 1.897 | Standard Error 0.041 | log 10 (log pg/ml) E2 | |
| Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist | B (PGL4001 10mg) | 1.843 | Standard Error 0.041 | log 10 (log pg/ml) E2 | |
| Co-primary Safety Endpoint: Serum Estradiol Levels at End of Treatment Visit (Week 13 Visit) for PGL4001 Compared With GnRHagonist | C (GnRH-agonist) | 1.381 | Standard Error 0.041 | log 10 (log pg/ml) E2 | |
| 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 | A (PGL4001 5mg) | 11.3 | -40.6 to -14.6 | percentage of patients |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A (PGL4001 5mg) | 97 | |
| Overall Study | STARTED | B (PGL4001 10mg) | 103 | |
| Overall Study | STARTED | C (GnRH-agonist) | 101 | |
| Overall Study | COMPLETED | A (PGL4001 5mg) | 93 | |
| Overall Study | COMPLETED | B (PGL4001 10mg) | 100 | |
| Overall Study | COMPLETED | C (GnRH-agonist) | 95 | |
| Overall Study | NOT COMPLETED | A (PGL4001 5mg) | 4 | |
| Overall Study | NOT COMPLETED | B (PGL4001 10mg) | 3 | |
| Overall Study | NOT COMPLETED | C (GnRH-agonist) | 6 |
Source ClinicalTrials.gov
Adverse events159
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Reproductive system and breast disorders | Reproductive system and breast disorders | A (PGL4001 5mg) | 39 | 97 | 50 |
| other | Reproductive system and breast disorders | Reproductive system and breast disorders | B (PGL4001 10mg) | 44 | 103 | 61 |
| other | Reproductive system and breast disorders | Reproductive system and breast disorders | C (GnRH-agonist) | 70 | 101 | 103 |
| other | Hot flush | Reproductive system and breast disorders | A (PGL4001 5mg) | 25 | 97 | 26 |
| other | Hot flush | Reproductive system and breast disorders | B (PGL4001 10mg) | 25 | 103 | 26 |
| other | Hot flush | Reproductive system and breast disorders | C (GnRH-agonist) | 66 | 101 | 79 |
| other | Dysmenorrhea | Reproductive system and breast disorders | A (PGL4001 5mg) | 4 | 97 | 6 |
| other | Dysmenorrhea | Reproductive system and breast disorders | B (PGL4001 10mg) | 5 | 103 | 5 |
| other | Dysmenorrhea | Reproductive system and breast disorders | C (GnRH-agonist) | 2 | 101 | 2 |
| other | Pelvic pain | Reproductive system and breast disorders | A (PGL4001 5mg) | 3 | 97 | 4 |
1 to 10 of 159Source ClinicalTrials.gov
See all 159 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A (PGL4001 5mg) | ||
| Total, all-cause mortality | B (PGL4001 10mg) | ||
| Total, all-cause mortality | C (GnRH-agonist) | ||
| Total, other adverse events | A (PGL4001 5mg) | 75 | 97 |
| Total, other adverse events | B (PGL4001 10mg) | 79 | 103 |
| Total, other adverse events | C (GnRH-agonist) | 85 | 101 |
| Total, serious adverse events | A (PGL4001 5mg) | 5 | 97 |
| Total, serious adverse events | B (PGL4001 10mg) | 4 | 103 |
| Total, serious adverse events | C (GnRH-agonist) | 4 | 101 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22296076 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00740831
GET https://conductscience.org/api/trials/v1/NCT00740831/events?page=2