Evaluations of Sexual Dysfunction of Female in Chronic Renal FailureNCT03172637
Female Sexual Dysfunction in Renal Failure
An observational study of Evaluations of Sexual Dysfunction of Female in Chronic Renal Failure, run by Esraa Ahmed Mohamed.
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 . Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Evaluations of Sexual Dysfunction of Female in Chronic Renal Failure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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.
Who may be able to join
- -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.
Who cannot join
- Pregnant women.
- Other medical diseases ( diabetes mellitus ,cardiac disorders ,neurological disorders and other systematic diseases).
- Taking medications affect sexuality function e.g. antidepressant drugs.
About this study
Official title: 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.
Read the 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 .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | 50 female end stage renal disease patients | |
| Group B | 50 normal female patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluations of Sexual Dysfunction of Female in Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Ahmed Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esraa Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172637
- Sponsor's protocol ID
- FSDRF
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Sexual Dysfunctions in Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT03172637
- Acronym / sponsor ID
- FSDRF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Esraa Ahmed MohamedUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –50 female end stage renal disease patients |
| Group B | – | –50 normal female patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- -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.
Key exclusion criteria (3 listed)
- Pregnant women.
- Other medical diseases ( diabetes mellitus ,cardiac disorders ,neurological disorders and other systematic diseases).
- Taking medications affect sexuality function e.g. antidepressant drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluations of Sexual Dysfunction of Female in Chronic Renal Failure, run by Esraa Ahmed Mohamed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of chronic renal failure in females on their sexuality function (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.