- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03172637
Female Sexual Dysfunction in Renal Failure
Female Sexual Dysfunctions in Patients With Chronic Renal Failure
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 .
Causes of sexual dysfunction in CKD include 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
Detailed Description
Hormonal changes in chronic kidney disease are seen in prolactine, gonadotropins, and gonadal hormones. In women with CKD, elevated levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) are common. These hormonal changes are detected in the early stages of kidney disease and progressively worsen as kidney disease progresse .
. Women with chronic renal failure commonly have elevated circulating prolactin levels. As in men with chronic renal failure, the hypersecretion of prolactin in this setting appears to be autonomous, as it is resistant to maneuvers designed to stimulate or inhibit its release.
It has been suggested that the elevated prolactin levels may impair hypothalamic-pituitary function and contribute to sexual dysfunction and galactorrhea in these patients. However, uremic women treated with bromocryptine rarely resume normal menses and continue to complain of galactorrhea (if present), despite normalization of the plasma prolactin concentration. Thus, factors other than hyperprolactinemia must be important in this setting .
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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 them in effect of renal failure on sexuality.
Duration of chronic renal failure duration of dialysis ,number of sessions of dialysis per week,medical treatment, haemoglobin and creatinine level will be fullfilled.
Description
Inclusion Criteria:
- -Female patients with chronic renal failure (eGFR <15 ml/min/1.7m2 ) on dialysis or not.
- Age from 18 to 45 years old.
- Married.
- Sexually active during the last 6 monthes.
Exclusion Criteria:
- Pregnant women.
- Other medical diseases ( diabetes mellitus ,cardiac disorders ,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 |
---|
Group A
50 female end stage renal disease patients
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Group B
50 normal female patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of chronic renal failure in females on their sexuality function
Time Frame: two years
|
compare sexuality function between female with chronic renal failure and normal female and observe difference between two groups
|
two years
|
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
- FSDRF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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