UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028769 |
|---|---|
| Receipt number | R000032922 |
| Scientific Title | The Pharmacokinetics of tadalafil in pregnant women and newborn infants |
| Date of disclosure of the study information | 2017/08/22 |
| Last modified on | 2019/03/11 11:20:50 |
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Basic information
Public title
The Pharmacokinetics of tadalafil in pregnant women and newborn infants
Acronym
The Pharmacokinetics of tadalafil in pregnant women
Scientific Title
The Pharmacokinetics of tadalafil in pregnant women and newborn infants
Scientific Title:Acronym
The Pharmacokinetics of tadalafil in pregnant women
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of pregnancy on pharmacokinetics of tadalafil
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The time course of serum concentration of tadalafil
Key secondary outcomes
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).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral administration of tadalafil 20 mg daily
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key 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.
Key exclusion criteria
Attending physician decides to entry inappropriate.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ikeda |
Organization
Mie university hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu-city
TEL
059-232-1111
tadafer.study@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Maki, Michiko Kubo, Takashi Umekawa |
Organization
Mie university hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-174 Edobashi, Tsu-city
TEL
059-232-1111
Homepage URL
tadafer.study@gmail.com
Sponsor or person
Institute
Mie university hospital, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
The Takeda Science Foundation.
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032922
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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