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A study of the safety of alpha1-blocker silodosin in adult women

A study of the safety of alpha1-blocker silodosin in adult women - Safety of alpha1-blocker silodosin in adult women

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009102
Enrollment
9
Registered
2012-10-12
Start date
2012-09-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urination impaired

Interventions

2 mg silodosin daily 4 mg silodosin daily 8 mg silodosin daily

Sponsors

Kinki University Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: No abnormalities found in health checkup. Must be capable of making outpatient hospital visits. Written informed consent can be obtained.

Exclusion criteria

Exclusion criteria: Patient with serious comorbid heart disease. Patient with serious comorbid liver disease or total bilirubin level more than 3 mg/dL or AST(GOT) or ALT(GPT) & 2.5 times the upper limit of the reference range. Patient with serious comorbid kidney disease or serum creatinine & more than 1.5 mg/dL. Patient with serious hypotension. Woman who is pregnant, nursing, wishes to become pregnant during the study period, or cannot follow physician's instructions regarding contraception. Patient who has taken another study drug or investigational drug within 1 month prior to beginning this study. Others judged to be unsuited as subjects according to the Principal Investigator.

Design outcomes

Primary

MeasureTime frame
Changes in blood pressure, pulse rate, and electrocardiogram waveform

Secondary

MeasureTime frame
I-PSS, OABSS, Uroflowmetry, PVR

Countries

Japan

Contacts

Public ContactNobutaka SHIMIZU

Kinki University Faculty of Medicine Department of Urology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026