Sexual Dysfunction in Hypertensive Women

NCT05156385 | Recruiting DMC

• 1 other identifier: RC31/19/0553
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

high blood pressure; antihypertensive drugs; sexual dysfunction

Outcome Measures

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

  25 months

Secondary Outcomes (3)

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

  25 months

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

  25 months

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

  25 months

Study Arms (1)

Hypertensive women

EXPERIMENTAL

Biological: Blood sample for the determination of antihypertensives or their metabolites.; Behavioral: Questionnaire on sexual activity; Behavioral: Scale on hospital anxiety and depression; Behavioral: Morisky Questionaire

Interventions

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

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

Hypertensive women

Questionnaire on sexual activity BEHAVIORAL

Questionnaire on sexual activity in women

Hypertensive women

Scale on hospital anxiety and depression BEHAVIORAL

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

Hypertensive women

Morisky Questionaire BEHAVIORAL

anti-hypertensive medication compliance questionnaire

Hypertensive women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with bariatric surgery,
• Patients under guardianship/trusteeship/protection of justice,
• Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

LAZARO Delphine

Toulouse, CHU de Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Hypertension; Sexual Dysfunction, Physiological

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Delphine LAZARO-VERGE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine LAZARO-VERGE

CONTACT

5 61 32 30 68; lazaro.d@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: December 14, 2021
• Study Start: June 27, 2022
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)