UMIN-CTR Clinical Trial

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
Email	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
Email	samehfayek@hotmail.com

Sponsor
Institute	Beni Suef University Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041269