- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03485261
Female Sexual Dysfunctions in Chronic Kidney Disease
Sexual Dysfunctions in Female Patients With Chronic Kidney Disease
A myriad of sexual problems affect men and women with chronic kidney disease (CKD), including decreased libido, erectile dysfunction, dysmenorrhea, and infertility. Menstrual abnormalities are common in CKD and many women are an-ovulatory.
Sexual dysfunction in CKD is multifactorial including hormonal alterations along with vascular, neurologic, psychogenic, and other factors, such as medications, contribute to the development of sexual dysfunction. Sexual dysfunction in females is mainly due to hormonal factors and manifests mainly as menstrual irregularities, amenorrhea, lack of vaginal lubrication, and failure to conceive.
Study Overview
Status
Conditions
Detailed Description
The study will be conducted on 100 female patients divided in to two equal group:
- Group A: The patient group include 50 female patients with chronic renal failure (eGFR <15ml/min/1.7m2 )
- Group B: The control group including 50 healthy females age matched with the patient group.
The Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.
Duration of chronic kidney disease, duration of dialysis ,number of sessions of dialysis per week, medical treatment, haemoglobin,creatinine level will be fulfilled.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Assiut, Egypt, 71621
- Recruiting
- Esraa Ahmed Mohamed
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Contact:
- ahmed samir, huxband
- Phone Number: 01150730888
- Email: drahmedsamir3344@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The study will be conducted on 100 female patients divided in to two equal group:
- Group A: The patient group include 50 female patients with chronic renal failure (eGFR <15ml/min/1.7m2 )
- Group B: The control group including 50 healthy females age matched with the patient group.
The Female Sexual Function Index (FSFI) will be used to assess sexual function. This index includes 19 questions related to 6 parameters: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and dyspareunia. A face-to-face inter-view with each participant in which the FSFI questions will be verbally asked and answered and compare between both groups in sexual activity and effect of chronic kidney disease on sexuality.
Duration of chronic kidney disease, duration of dialysis, number of sessions of dialysis per week, medical treatment, haemoglobin, creatinine level will be fulfilled.
Description
Inclusion Criteria:
- Female patients with chronic kidney disease stage 5 with estimated glomerular filtration rate (eGFR) <15 ml/min/1.7m2 using the equation of MDRD (modification of diet in renal disease) on dialysis or not.
- Age from 18 to 45 years old.
- Married.
- Sexually active during the last 6 months.
Exclusion Criteria:
- Pregnant women.
- Other medical diseases (diabetes mellitus, coronary artery disease, neurological disorders and other systematic diseases).
- Taking medications affect sexuality function e.g. antidepressant drugs.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group A
patient group include 50 female patients with chronic renal failure (eGFR <15ml/min/1.7m2
)
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Group B
the control group including 50 healthy females age matched with the patient group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluation of female sexual dysfunctions in patients with chronic kidney disease.
Time Frame: one year
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questionnaire to female patients with chronic kidney disease
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one year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSDCKD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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