Sexual Dysfunction in Hypertensive Women (DYSFHO)
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample for the determination of antihypertensives or their metabolites.
Questionnaire on sexual activity
Scale on hospital anxiety and depression
Morisky Questionaire
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension focused on measuring high blood pressure, antihypertensive drugs, sexual dysfunction
Eligibility Criteria
Inclusion Criteria:
- Women over 18,
- Hospitalized or received in consultation for the management of hypertension treated in one of the hypertension and therapeutic, nephrology or cardiology departments participating in the study, with confirmed hypertension, treated with the following dosable antihypertensive agent(s): diltiazem, verapamil, acebutolol, atenolol, nébivolol, bisoprolol, metoprolol, propranolol, amiloride, furosemide, hydrochlorothiazide, indapamide, spironolactone, spironolactone , Lorsartan, Irbesartan, Ramipril, Perindopril, Amlodipine,
- Having signed the informed consent form.
- Beneficiary or affiliated to a French Social insurance
Exclusion Criteria:
- Patients with bariatric surgery,
- Patients under guardianship/trusteeship/protection of justice,
- Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.
Sites / Locations
- LAZARO DelphineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypertensive women
Arm Description
Outcomes
Primary Outcome Measures
Analyse of sexual dysfunction
Prevalence of sexual dysfunction defined by a score less than 26 on the Female Sexual Function Index scale : score less than 26 mean a sexual dysfunction
Secondary Outcome Measures
Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire
Compare two methods of assessing drug compliance: drug dosages in the blood and the Morisky questionnaire; The score is rated on 8 points. A score of 8 is considered "good observant", a score between 6 and 7 "moderately observant patient" and a score strictly lower than 6 "poor observant".
Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used
Estimate the prevalence of sexual dysfunction according to the antihypertensive pharmacological classes used (in the biologicale analysis)
Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;
Estimate the prevalence of sexual dysfunction according to the number of antihypertensive treatments;
Full Information
NCT ID
NCT05156385
First Posted
October 15, 2021
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT05156385
Brief Title
Sexual Dysfunction in Hypertensive Women
Acronym
DYSFHO
Official Title
Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
June 7, 2024 (Anticipated)
Study Completion Date
June 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Several studies describe the existence of an association between sexual dysfunction and high blood pressure (hypertension), most often characterized by a decrease in the number of orgasms and the existence of dyspareunia.
Hypertension is a contributing factor, and nonadherence to medication could amplify it.
There are several ways to assess adherence to treatment: the use of declarative questionnaires, a method not without criticism because it is subject to the subjectivity of the declaration by the patient; and drug dosages, a standard technique, although insufficiently disseminated due to the high cost and greater weight of the survey protocols. Drug non-compliance is multifactorial. In addition, it has been shown that having undesirable drug effects and / or being afraid of developing them is one of the major causes of non-compliance with antihypertensive treatments.
The investigators hypothesize that DS is significantly more common among hypertensive women treated with non-observers compared to hypertensive women treated with observers.
The main objective is to compare the prevalence of sexual dysfunction between a group of hypertensive women treated as observers and a group of hypertensive women treated as non-observers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
high blood pressure, antihypertensive drugs, sexual dysfunction
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
348 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypertensive women
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Blood sample for the determination of antihypertensives or their metabolites.
Intervention Description
15 ml of Blood sample for the determination of antihypertensives or their metabolites
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire on sexual activity
Intervention Description
Questionnaire on sexual activity in women
Intervention Type
Behavioral
Intervention Name(s)
Scale on hospital anxiety and depression
Intervention Description
Scale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions)
Intervention Type
Behavioral
Intervention Name(s)
Morisky Questionaire
Intervention Description
anti-hypertensive medication compliance questionnaire
Primary Outcome Measure Information:
Title
Analyse of sexual dysfunction
Description
Prevalence of sexual dysfunction defined by a score less than 26 on the Female Sexual Function Index scale : score less than 26 mean a sexual dysfunction
Time Frame
25 months
Secondary Outcome Measure Information:
Title
Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire
Description
Compare two methods of assessing drug compliance: drug dosages in the blood and the Morisky questionnaire; The score is rated on 8 points. A score of 8 is considered "good observant", a score between 6 and 7 "moderately observant patient" and a score strictly lower than 6 "poor observant".
Time Frame
25 months
Title
Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used
Description
Estimate the prevalence of sexual dysfunction according to the antihypertensive pharmacological classes used (in the biologicale analysis)
Time Frame
25 months
Title
Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;
Description
Estimate the prevalence of sexual dysfunction according to the number of antihypertensive treatments;
Time Frame
25 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women over 18,
Hospitalized or received in consultation for the management of hypertension treated in one of the hypertension and therapeutic, nephrology or cardiology departments participating in the study, with confirmed hypertension, treated with the following dosable antihypertensive agent(s): diltiazem, verapamil, acebutolol, atenolol, nébivolol, bisoprolol, metoprolol, propranolol, amiloride, furosemide, hydrochlorothiazide, indapamide, spironolactone, spironolactone , Lorsartan, Irbesartan, Ramipril, Perindopril, Amlodipine,
Having signed the informed consent form.
Beneficiary or affiliated to a French Social insurance
Exclusion Criteria:
Patients with bariatric surgery,
Patients under guardianship/trusteeship/protection of justice,
Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine LAZARO-VERGE
Phone
5 61 32 30 68
Ext
+33
Email
lazaro.d@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine LAZARO-VERGE, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAZARO Delphine
City
Toulouse Cedex 9
State/Province
CHU De Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delphine LAZARO
Phone
5 61 32 30 68
Ext
+33
Email
lazaro.d@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Audrey TOMASIK
Phone
561778597
Ext
+33
Email
tomasik.a@chu-toulouse.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sexual Dysfunction in Hypertensive Women
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