Clinical trial NCT05156385: Sexual Dysfunction in Hypertensive Women
Official title: Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: high blood pressure
antihypertensive drugs
sexual dysfunction
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 348
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Analyse of sexual dysfunction
timeFrame: 25 months
Secondary outcomes:
measure: Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire
timeFrame: 25 months
measure: Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used
timeFrame: 25 months
measure: Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;
timeFrame: 25 months
Other outcomes:
Locations:
city: Toulouse Cedex 9
country: France
facility: LAZARO Delphine
state: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Delphine LAZARO-VERGE, MD
role: PRINCIPAL_INVESTIGATOR
References: