UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036225 |
|---|---|
| Receipt number | R000041269 |
| Scientific Title | Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study |
| Date of disclosure of the study information | 2019/06/19 |
| Last modified on | 2021/02/02 16:00:54 |
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Basic information
Public title
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
Acronym
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
Scientific Title
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
Scientific Title:Acronym
Adapting Healthy Life Style Program is More Effective Than Atorvastatin in Improving Sexual Function in Hypercholestrolemic Females: A Pilot Prospective Study
Region
| Africa |
Condition
Condition
sexual dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed in our study to evaluate the impact of atorvastatin therapy against adapting healthy life style program on sexual function in young women with high cholesterol levels as well as ambulatory blood pressure and lipids profile.
Basic objectives2
Others
Basic objectives -Others
We aimed in our study to evaluate the impact of atorvastatin therapy against adapting healthy life style program on sexual function in young women with high cholesterol levels as well as ambulatory blood pressure and lipids profile.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
lowering of lipids profile and ambulatory blood pressure
Key secondary outcomes
improvement of female sexual function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
30 patients received atorvastat20-40 mg daily for 6 months (group A)
Interventions/Control_2
30 patients adapted healthy life style program for 6 months (group B)
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
| 25 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
females with hypercholestrolemia
Key exclusion criteria
Any woman with chronic debilitating diseases, any past history of urogynecological operations were excluded from the study. Also, pregnant or lactating women or women who received systemic hormones as contraceptives or replacement therapy were excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | sameh |
| Middle name | fayek GamalEl Din |
| Last name | Saleh |
Organization
Kasr Al-Ainy Faculty of medicine Cairo university
Division name
Andrology & STDs
Zip code
202
Address
El saray street El manial
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | sameh |
| Middle name | fayek GamalEl Din |
| Last name | Saleh |
Organization
Kasr Al-Ainy Faculty of medicine Cairo university
Division name
Andrology & STDs
Zip code
202
Address
El saray street El manial
TEL
01227109309
Homepage URL
samehfayek@hotmail.com
Sponsor or person
Institute
Beni Suef University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Beni Suef University Faculty of Medicine
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
Beni Suef University, Faculty of medicine, Cairo, Egypt
Address
Beni Suef, Egypt
Tel
082 2356845
nashaatnabil@windowslive.com
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
| 2019 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Healthy life style is more effective than atorvastatin in improving sexual function
Publication of results
Unpublished
Result
URL related to results and publications
Healthy life style is more effective than atorvastatin in improving sexual function
Number of participants that the trial has enrolled
60
Results
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
Results date posted
| 2021 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
Participant flow
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
Adverse events
No adverse side effects were recorded
Outcome measures
Although, atorvastatin was associated with significant reduction in pain sensation during intercourse and non-significant improvement in orgasm domain, yet, adapting healthy life style program can be more effective on lowering hyperlipidemia as well as improving sexual function especially in young females not suffering from any associated comorbidities.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 26 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 16 | Day |
Last modified on
| 2021 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041269
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