UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060711 |
|---|---|
| Receipt number | R000068728 |
| Scientific Title | Standardization of sexual health education in patients with pulmonary hypertension |
| Date of disclosure of the study information | 2026/02/20 |
| Last modified on | 2026/02/20 11:36:53 |
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Basic information
Public title
Standardization of sexual health education in patients with pulmonary hypertension
Acronym
Standardization of sexual health education in patients with pulmonary hypertension
Scientific Title
Standardization of sexual health education in patients with pulmonary hypertension
Scientific Title:Acronym
Standardization of sexual health education in patients with pulmonary hypertension
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Utilize brochures that explain the risks of pregnancy and childbirth for patients with pulmonary hypertension and their partners to provide comprehensive sexuality education, and examine the appropriate support methods for helping patients make the best choices through a survey.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Based on questionnaire responses, understanding of risks of pregnancy and childbirth, desire for pregnancy, and relationship with partner. Assessment of disease severity based on patient-related factors
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Questionnaire
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with pulmonary hypertension based on the Japanese Circulation Society Joint Research Group 'Guidelines for the Treatment of Pulmonary Hypertension' (2017 revised edition)
Patients whose partner status has been identified through self-reporting or necessary medical interviews
Key exclusion criteria
Patients whose pulmonary hypertension has worsened, resulting in low exercise tolerance and making sexual activity impossible. Patients who have other medical reasons judged to make sexual activity impossible.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Sapporo Medical Unversity
Division name
Departemnt of Patient Safety and Hospital Administration
Zip code
0608543
Address
S1W16 Chuo-ku, Sapporo
TEL
0116112111
ahashimo@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Hashimoto |
Organization
Sapporo Medical University
Division name
Departemnt of Patient Safety and Hospital Administration
Zip code
060-8543
Address
S1W16 Chuo-ku, Sapporo
TEL
011611211
Homepage URL
ahashimo@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical Unversity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical Unversity Clinical Research Review Committee
Address
S1W16, Chuo-ku, Sapporo
Tel
0116112111
ahashimo@sapmed.ac.jp
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
| 2026 | Year | 02 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 20 | Day |
Last modified on
| 2026 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068728
