The Pharmacokinetics of tadalafil in pregnant women and newborn infants

The Pharmacokinetics of tadalafil in pregnant women and newborn infants - The Pharmacokinetics of tadalafil in pregnant women

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028769

Enrollment

Registered

2017-08-22

Start date

2017-04-10

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

Pregnant women

Interventions

oral administration of tadalafil 20 mg daily

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age>=20 and <45. 2. Gestational age between 20 + 0 and 33 + 6 weeks in pregnant women. 3. The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan (2014) in pregnant women. 4. Written informed consent.

Exclusion criteria

Exclusion criteria: Attending physician decides to entry inappropriate.

Design outcomes

Primary

Measure	Time frame
The time course of serum concentration of tadalafil	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Japan

Contacts

Public ContactShintaro Maki, Michiko Kubo, Takashi Umekawa

Mie university hospital Department of Obstetrics and Gynecology

tadafer.study@gmail.com059-232-1111

Outcome results

None listed

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