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Sexual Dysfunction in Hypertensive Women

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05156385
Acronym
DYSFHO
Enrollment
348
Registered
2021-12-14
Start date
2022-06-27
Completion date
2027-07-07
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

high blood pressure, antihypertensive drugs, sexual dysfunction

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.

Interventions

BIOLOGICALBlood sample for the determination of antihypertensives or their metabolites.

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

BEHAVIORALQuestionnaire on sexual activity

Questionnaire on sexual activity in women

BEHAVIORALScale on hospital anxiety and depression

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

BEHAVIORALMorisky Questionaire

anti-hypertensive medication compliance questionnaire

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Analyse of sexual dysfunction25 monthsPrevalence 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

MeasureTime frameDescription
Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire25 monthsCompare 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 antihypertensive pharmacological classes used25 monthsEstimate the prevalence of sexual dysfunction according to the antihypertensive pharmacological classes used (in the biologicale analysis)
Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;25 monthsEstimate the prevalence of sexual dysfunction according to the number of antihypertensive treatments;

Countries

France

Contacts

CONTACTDelphine LAZARO-VERGE
lazaro.d@chu-toulouse.fr5 61 32 30 68
PRINCIPAL_INVESTIGATORDelphine LAZARO-VERGE, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026