Sexual Dysfunction in Hypertensive Women

NCT ID: NCT05156385

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2026-07-07

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Hypertensive women

Group Type EXPERIMENTAL

Blood sample for the determination of antihypertensives or their metabolites.

Intervention Type BIOLOGICAL

15 ml of Blood sample for the determination of antihypertensives or their metabolites

Questionnaire on sexual activity

Intervention Type BEHAVIORAL

Questionnaire on sexual activity in women

Scale on hospital anxiety and depression

Intervention Type BEHAVIORAL

Scale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions)

Morisky Questionaire

Intervention Type BEHAVIORAL

anti-hypertensive medication compliance questionnaire

Interventions

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Blood sample for the determination of antihypertensives or their metabolites.

15 ml of Blood sample for the determination of antihypertensives or their metabolites

Intervention Type BIOLOGICAL

Questionnaire on sexual activity

Questionnaire on sexual activity in women

Intervention Type BEHAVIORAL

Scale on hospital anxiety and depression

Scale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions)

Intervention Type BEHAVIORAL

Morisky Questionaire

anti-hypertensive medication compliance questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine LAZARO-VERGE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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LAZARO Delphine

Toulouse, CHU de Toulouse, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Delphine LAZARO-VERGE

Role: CONTACT

5 61 32 30 68 ext. +33

Facility Contacts

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Delphine LAZARO

Role: primary

5 61 32 30 68 ext. +33

Audrey TOMASIK

Role: backup

561778597 ext. +33

Other Identifiers

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RC31/19/0553

Identifier Type: -

Identifier Source: org_study_id

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