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NCT Number: NCT05156385

Sexual Dysfunction in Hypertensive Women

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample for the determination of antihypertensives or their metabolites.

Biological

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

Primary outcomes

  1. Analyse of sexual dysfunction

    Time frame: 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 outcomes

  1. Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire

    Time frame: 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".

  2. Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used

    Time frame: 25 months

    Estimate the prevalence of sexual dysfunction according to the antihypertensive pharmacological classes used (in the biologicale analysis)

  3. Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;

    Time frame: 25 months

    Estimate the prevalence of sexual dysfunction according to the number of antihypertensive treatments;

Study contacts

Contact information is provided by the study sponsor or research team.

Delphine LAZARO-VERGE

CONTACT

[email protected]

5 61 32 30 68 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: DYSFHO

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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