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

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-22
• Study Completion: 2018-04-10
• Last Update Posted: 17 October 2023

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

Name	Time	Method
The time course of serum concentration of tadalafil

Secondary Outcome Measures

Name	Time	Method
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).