PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII)
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| ClinicalTrials.gov Identifier: NCT01156857 |
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Recruitment Status :
Completed
First Posted : July 5, 2010
Last Update Posted : January 15, 2016
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Sponsor:
PregLem SA
Information provided by (Responsible Party):
PregLem SA
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Brief Summary:
This is a multicentre, Phase III, efficacy and safety open-label study with PGL4001 10mg once daily for 3 months, blinded towards the administration of progestin or placebo after end of PGL4001 treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uterine Fibroids | Drug: PGL4001, placebo Drug: PGL4001, progestin | Phase 3 |
PGL4001 will be administered daily to all subjects in an open-label manner with no control group. The three months open label treatment period will be followed by a ten day double blind treatment with progestin or matching placebo. Subjects will be randomly assigned to progestin or matching placebo arm with a 1:1 ratio.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 209 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Multicentre, Clinical Study Investigating the Efficacy and Safety of 3-months Open-label Treatment With PGL4001, Followed by a Randomised, Double-blind Placebo Controlled Period of 10 Days Treatment With Progestin, in Subjects With Myomas and Heavy Uterine Bleeding. |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | November 2011 |
| Actual Study Completion Date : | February 2012 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ulipristal acetate
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
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Drug: PGL4001, placebo
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
Other Name: Ulipristal acetate |
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Experimental: B
Drug: PGL4001 10mg (oral tablets) for 3 months followed by a period of 10 days of progestin (oral tablets).
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Drug: PGL4001, progestin
PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).
Other Name: Ulipristal acetate |
Primary Outcome Measures :
- Efficacy endpoints [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) and to approximately 2 weeks after double blind treatment with progestin/placebo. ]Investigate efficacy of PGL4001 on uterine bleeding (% of subjects in amenorrhea at end of PGL4001 treatment), myoma size (transvaginal ultrasound), pain (short Mc Gill questionnaire) and quality of life (specific UFS-QoL questionnaire and general EQ-5D questionnaire).
- Number and proportion of subjects experiencing open label treatment-emergent adverse events [ Time Frame: From baseline to end of PGL4001 treatment (3months treatment) ]
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| Ages Eligible for Study: | 18 Years to 48 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is a pre-menopausal woman aged between 18 and 48 years inclusive.
- Subject with a Body Mass Index ≥18 and ≤40.
- Subject with myomatous uterus size < 16 weeks.
- Subject must have at least one uterine myoma of at least 3 cm diameter in size and no myoma larger than 10 cm diameter diagnosed by ultrasound.
- Subject complained of strong uterine bleeding.
- Subject is eligible for hysterectomy or myomectomy.
- Females of childbearing potential have to practice a non-hormonal method of contraception.
Exclusion Criteria:
- Subject has a history of or current uterus, cervix, ovarian or breast cancer.
- Subject has a history of endometrium hyperplasia or adenocarcinoma in a biopsy performed within the past 6 months or similar lesions in the screening biopsy.
- Subject has a known severe coagulation disorder.
- Subject has a history of treatment for myoma with a SPRM, including ulipristal acetate.
- Subject has abnormal hepatic function at study entry.
Information from the National Library of Medicine
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): NCT01156857
Locations
Show 23 study locations
Sponsors and Collaborators
PregLem SA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | PregLem SA |
| ClinicalTrials.gov Identifier: | NCT01156857 |
| Other Study ID Numbers: |
PGL09-026 |
| First Posted: | July 5, 2010 Key Record Dates |
| Last Update Posted: | January 15, 2016 |
| Last Verified: | June 2013 |
Additional relevant MeSH terms:
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Leiomyoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Ulipristal acetate Progestins |
Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |