An observational study in Benign Prostatic Hyperplasia and Prostatic Hyperplasia, sponsored by GlaxoSmithKline. Completed at 1 site in Korea, Republic of. Open to male participants. Per ClinicalTrials.gov, last updated 2017-07-05.
Sponsored by GlaxoSmithKline · Observational
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of AVODART administered in Korean BPH patients according to the prescribing information
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 3,977 is above the median of 214 across 167 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
The Korean BPH Patients administrated dutasteride
Exclusion Criteria:
Patients administrated dutasteride at the site
Drug: Dutasteride
Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
Number of Participants With an Adverse Event
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
Time frame: 6 months
Number of Participants With a Serious Adverse Event
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
Time frame: 6 months
Number of Participants With the Indicated Unexpected Adverse Events
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Time frame: 6 months
The objective of this post-marketing surveillance (PMS) study was to assess the occurrence of adverse events reported after administration of Avodart in Korean benign prostatic hyperplasia (BPH) patients.
| Milestone | Avodart 0.5 mg |
|---|---|
| Started | 3977 |
| Completed | 3870 |
| Not completed | 107 |
| Withdrew: Protocol violation | 107 |
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.
| participants | Avodart 0.5 mg |
|---|---|
| Number of Participants With an Adverse Event | 146 |
A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.
| participants | Avodart 0.5 mg |
|---|---|
| Number of Participants With a Serious Adverse Event | 5 |
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
| participants | Avodart 0.5 mg |
|---|---|
| Insomnia | 2 |
| Mouth Dry | 3 |
| Constipation | 2 |
| Abdominal Pain | 2 |
| Diarrhea | 2 |
| Vomiting | 1 |
| Colonic Polyp | 1 |
| Epigastric Discomfort | 1 |
| Gastroesophageal Reflux | 1 |
| Hemorrhoids | 1 |
| Asthenia | 1 |
| Fever | 1 |
| Chills | 1 |
| Pain | 1 |
| Spasms | 1 |
| Orofacial Dyskinesia | 1 |
| Embolism Pulmonary | 1 |
| Thrombosis Cerebral | 1 |
| Nose Congestion | 1 |
| Pneumonia | 1 |
| Lung Carcinoma | 1 |
| Skin Eruption | 1 |
| Thrombosis Venous Deep | 1 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Avodart 0.5 mg | — | 5/3,870 (0.1%) | 146/3,870 (3.8%) |
| Event | Avodart 0.5 mg |
|---|---|
| DiarrheaGastrointestinal disorders | 1/3870 |
| Embolism PulmonaryRespiratory, thoracic and mediastinal disorders | 1/3870 |
| Thrombosis CerebralBlood and lymphatic system disorders | 1/3870 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 1/3870 |
| Lung CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3870 |
| Event | Avodart 0.5 mg |
|---|---|
| ImpotencePsychiatric disorders | 72/3870 |
| Libido DecreasedPsychiatric disorders | 49/3870 |
| Ejaculation DisorderReproductive system and breast disorders | 30/3870 |
| DyspepsiaGastrointestinal disorders | 6/3870 |
| GynaecomastiaEndocrine disorders | 5/3870 |
| Mouth DryGastrointestinal disorders | 3/3870 |
| InsomniaPsychiatric disorders | 2/3870 |
| ConstipationGastrointestinal disorders | 2/3870 |
| Abdominal PainGastrointestinal disorders | 2/3870 |
| DizzinessNervous system disorders | 2/3870 |
| Age, Continuous(Years) | Avodart 0.5 mg |
|---|---|
| Mean | 67.3 ± 9.1 |
| Sex: Female, Male(Participants) | Avodart 0.5 mg |
|---|---|
| Female | 0 |
| Male | 3870 |
| Race/Ethnicity, Customized(participants) | Avodart 0.5 mg |
|---|---|
| Korean | 3870 |
| Not Korean | 0 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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