Sexual Dysfunction in Hypertensive Women

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Biological: Blood sample for the determination of antihypertensives or their metabolites.; Behavioral: Questionnaire on sexual activity; Behavioral: Scale on hospital anxiety and depression; Behavioral: Morisky Questionaire

• Registration Number: NCT05156385
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-11-30
• Study First Posted: 2021-12-14
• Study Start: 2022-06-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2026-07-07
• Study Completion: 2026-07-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 348

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypertensive women	Questionnaire on sexual activity	-
Hypertensive women	Scale on hospital anxiety and depression	-
Hypertensive women	Morisky Questionaire	-
Hypertensive women	Blood sample for the determination of antihypertensives or their metabolites.	-

Primary Outcome Measures

Name	Time	Method
Analyse of sexual dysfunction	25 months	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

Name	Time	Method
Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire	25 months	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 number of antihypertensive treatments;	25 months	Estimate the prevalence of sexual dysfunction according to the number of antihypertensive treatments;
Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used	25 months	Estimate the prevalence of sexual dysfunction according to the antihypertensive pharmacological classes used (in the biologicale analysis)

Trial Locations

Locations (1)

LAZARO Delphine; 🇫🇷 Toulouse Cedex 9, CHU de Toulouse, France