Viewing Study NCT03485261


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Study NCT ID: NCT03485261
Status: UNKNOWN
Last Update Posted: 2018-04-02
First Post: 2018-03-27
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Female Sexual Dysfunctions in Chronic Kidney Disease
Sponsor: Assiut University
Organization:

Study Overview

Official Title: Sexual Dysfunctions in Female Patients With Chronic Kidney Disease
Status: UNKNOWN
Status Verified Date: 2018-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: The study will be conducted on 100 female patients divided in to two equal group:

1. Group A: The patient group include 50 female patients with chronic renal failure (eGFR \<15ml/min/1.7m2 )
2. 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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: