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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03172637
Other study ID # FSDRF
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 30, 2017
Last updated May 30, 2017
Start date July 1, 2017
Est. completion date December 31, 2018

Study information

Verified date May 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .

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.


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Esraa Ahmed Mohamed

Outcome

Type Measure Description Time frame Safety issue
Primary effect of chronic renal failure in females on their sexuality function compare sexuality function between female with chronic renal failure and normal female and observe difference between two groups two years