Health TrialsbyHealthPanel

Sexual Dysfunction in Hypertensive Women

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with bariatric surgery,

Patients under guardianship/trusteeship/protection of justice,

Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sample for the determination of antihypertensives or their metabolites.

    Biological/Vaccine

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

  • Questionnaire on sexual activity

    Behavioral

    Questionnaire on sexual activity in women

  • Scale on hospital anxiety and depression

    Behavioral

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

  • Morisky Questionaire

    Behavioral

    anti-hypertensive medication compliance questionnaire

Treatment groups

348 Participants
are divided into 1 treatment group
Group A: Hypertensive womenExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
25 months

Secondary outcomes

1

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".

Time frame
25 months
2

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)

Time frame
25 months
3

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;

Time frame
25 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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