臨床研究等提出・公開システム

Safety trial of tadalafil administered during labor A phase-1 clinical study (TADAFL)

TADAFL

6

The mean maternal age was 34.3 years. Pregnancy history included primipara 2 cases and multipara 4 cases.

Seven cases were enrolled, one of which was discontinued, leaving a total of six implementation cases. Six of the cases were recruited after completion of the examination and observation as specified in the study protocol.

Illnesses, etc. suspected to have been caused by the specific clinical research: None Serious adverse events: 0 Adverse events: Maternal: 9 (abnormal white blood cell count: 1, abnormal hemoglobin: 1, headache: 2, anorexia: 2, myalgia: 1, palpitations: 2), neonatal: 5 (neonatal transient hypercapnia: 2, fetal aspiration syndrome: 1, abnormal ABR: 2)

Primary endpoint: No maternal serious adverse events associated with tadalafil. Secondary endpoints: Tadalafil pharmacokinetics were Cmax 176.1 ng/mL, Tmax 3.3hr. No serious adverse events associated with dalafil in neonates.

There were 9 maternal and 5 neonatal adverse events, but no tadalafil-related adverse events were observed in either mothers or neonates. Tadalafil administration during labor and delivery is considered safe for both mother and neonate.

April. 30, 2023

No

not applicable

https://jrct.mhlw.go.jp/latest-detail/jRCTs041210073

Tanaka Hiroaki

Mie University Hospital

2-174 Edobashi, Tsu, Mie

tanaka-hiroaki@med.mie-u.ac.jp

Tanaka Hiroaki

Mie University Hospital

2-174 Edobashi, Tsu, Mie

+81-592321111

tanaka-hiroaki@med.mie-u.ac.jp

Complete

Sept. 22, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

20 years old and under 45 years old
It is predicted that the baby will be delivered after 37 weeks of gestation and less than 42 weeks.
28 weeks or more and less than 41 weeks gestation
The expected delivery date has been determined in accordance with the Obstetrics and Gynecology Practice Guidelines Obstetrics Edition 2020.
Single fetal flow.
A written consent has been obtained from the person mother regardingregarding participation in the test.

Pregnant women whose delivery method is defined as cesarean section before the start of labor (previous cesarean section, post myomectomy.
Has a history of hypersensitivity to tadalafil.
Patients who used PDE5 inhibitors containing tadalafil during this pregnancy.
I am taking a drug that is contraindicated in combination with the drug in the package insert of tadalafil.
Patients undergoing renal dialysis or having severe renal dysfunction with measured or estimated creatinine clearance of less than 30 mL / min.
Patients with severe hepatic disorder [patients with AST (GOT) or ALT (GPT) of 100 IU / L or more].
Patients with uncontrolled arrhythmia, hypotension (blood pressure <80/40 mmHg) or uncontrolled hypertension (resting blood pressure> 170/100 mmHg).
When fetal morphological abnormalities including multiple malformations that may be chromosomal abnormalities are observed in the foetation by fetal ultrasonography.
Patients with retinitis pigmentosa, hemorrhagic disease, peptic ulcer, or pulmonary vein obstructive disease.
Patients who are judged by the principal investigator or the investigator to be unsuitable for the study.

Female

Pregnancy Singlton

Cohort I:
Start taking tadalafil 10 mg (Zartia Coupling Tablets 5 mg, 2 tablets) from the beginning of labor, and take the same amount every 12 hours.
Cohort II:
Start oral administration of tadalafil 20 mg (Zartia coupling tablets 5 mg, 4 tablets) from the start of labor, and take the same amount every 12 hours.

Maternal Safty

Pharmacokinetic parameters: AUC0 12, Cmax
Comparison of placental PlGF and prepartum PlGF in cesarean section and transvaginal delivery by fetal adaptation, adverse events in newborns

+81-59-231-5045

July. 26, 2021

None