ClinicalTrials.gg
RecruitingNCT05156385DYSFHOUpdated Jun 1, 2026

Sexual Dysfunction in Hypertensive Women

An interventional study of Blood sample for the determination of antihypertensives or their metabolites. and Questionnaire on sexual activity in Hypertension, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
348
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Hypertension

Keywords

  • high blood pressure
  • antihypertensive drugs
  • sexual dysfunction
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 348 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.
  • Beneficiary or affiliated to a French Social insurance

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
348 participants (estimated)

Study arms

  • Experimental
    Hypertensive women

    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

  • 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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05156385
Responsible party
Sponsor
First posted
Dec 14, 2021
Start date
Jun 27, 2022
Primary completion
Jul 7, 2027 (estimated)
Completion
Jul 7, 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Delphine LAZARO-VERGE
Contact
lazaro.d@chu-toulouse.fr
5 61 32 30 68 ext. +33
Delphine LAZARO-VERGE, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion