Sexual Dysfunction in Hypertensive Women

Hypertension Clinical Trial

— DYSFHO  

Official title:

Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156385
• Other study ID #: RC31/19/0553
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: June 7, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: Delphine LAZARO-VERGE
• Phone: 5 61 32 30 68
• Email: lazaro.d[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: June 7, 2024
• Est. primary completion date: June 7, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Biological:
• Blood sample for the determination of antihypertensives or their metabolites.
15 ml of Blood sample for the determination of antihypertensives or their metabolites

Behavioral:
• Questionnaire on sexual activity
Questionnaire on sexual activity in women
• Scale on hospital anxiety and depression
Scale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions)
• Morisky Questionaire
anti-hypertensive medication compliance questionnaire

Locations

Country	Name	City	State
France	LAZARO Delphine	Toulouse Cedex 9	CHU De Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	25 months
Secondary	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".	25 months
Secondary	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)	25 months
Secondary	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;	25 months