UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053844 |
|---|---|
| Receipt number | R000061425 |
| Scientific Title | Evaluation of female sexual function and desire among controlled and uncontrolled hypertensive female patients: a prospective randomized control study |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/13 08:17:30 |
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Basic information
Public title
Evaluation of female sexual function and desire among controlled and uncontrolled hypertensive female patients: a prospective randomized control study
Acronym
Evaluation of female sexual function and desire among controlled and uncontrolled hypertensive female patients: a prospective randomized control study
Scientific Title
Evaluation of female sexual function and desire among controlled and uncontrolled hypertensive female patients: a prospective randomized control study
Scientific Title:Acronym
Evaluation of female sexual function and desire among controlled and uncontrolled hypertensive female patients: a prospective randomized control study
Region
| Africa |
Condition
Condition
female sexual dysfunction
Classification by specialty
| Cardiology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the presence of sexual dysfunction in hypertensive women
Basic objectives2
Others
Basic objectives -Others
To identify the relationship of FSD & antihypertensive drugs (Beta Blockers & Angiotensin converting enzyme inhibitors/Angiotensin receptor blockers)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify the presence of sexual dysfunction in hypertensive women
Key secondary outcomes
to identify the relationship of FSD & antihypertensive drugs (Beta Blockers & Angiotensin converting enzyme inhibitors/Angiotensin receptor blockers)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
25 Normotensive female controls
Interventions/Control_2
25 Hypertensive female receiving BB & controlled
Interventions/Control_3
25 Hypertensive female receiving BB & uncontrolled
Interventions/Control_4
25 Hypertensive female receiving ACEI/ARBs & controlled
Interventions/Control_5
25 Hypertensive female receiving ACEI/ARBs & uncontrolled
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
18 years to 45 years
Key exclusion criteria
breastfeeding women
diabetes mellitus
Obesity
smoking
history of breast cancer or thromboembolic diseases
major cardiovascular disease non-cardiovascular disease
non-sexually active women
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Cairo university
Division name
Andrology & STDs
Zip code
002
Address
South academy, New cairo, Cairo
TEL
002025729584
samehfayek@kasralainy.edu.eg
Public contact
Name of contact person
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Cairo University
Division name
Andrology & STDs
Zip code
002
Address
South academy, New cairo, Cairo
TEL
002025729584
Homepage URL
http://scholar.cu.edu.eg/sfayek
samehfayek@kasralainy.edu.eg
Sponsor or person
Institute
Cairo university
Institute
Department
Personal name
sameh fayek gamalEl Din
Funding Source
Organization
Cairo university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cairo university
Address
South academy, New cairo, Cairo
Tel
0020 25 729 584
samehfayek@kasralainy.edu.eg
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
| 2024 | Year | 03 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 14 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 14 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061425
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
