MedPath

The Pharmacokinetics of tadalafil in pregnant women and newborn infants

Not Applicable
Conditions
Pregnant women
Registration Number
JPRN-UMIN000028769
Lead Sponsor
Mie university hospital, Department of Obstetrics and Gynecology
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

Attending physician decides to entry inappropriate.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The time course of serum concentration of tadalafil
Secondary Outcome Measures
NameTimeMethod
1. The effect of pregnancy on serum concentration of tadalafil. 2. The effect of pregnancy on urine concentration of cGMP. 3. The effect of complications during pregnancy (FGR and PIH) on serum concentration of tadalafil. 4. The effect of complications during pregnancy (FGR and PIH) on urine concentration of cGMP. 5. The effect of pregnancy on blood pressure after administration of tadalafil. 6. The effect of complications during pregnancy (FGR and PIH) on blood pressure after administration of tadalafil. 7. The time course of serum concentration of tadalafil in newborn infants. 8. The effect of twin pregnancy on the outcomes above (No.1-7).
© Copyright 2025. All Rights Reserved by MedPath