HypertensionDYSFHONCT05156385
Sexual Dysfunction in Hypertensive Women
A study testing Blood sample for the determination of antihypertensives or their metabolites., Questionnaire on sexual activity and Scale on hospital anxiety and depression in people with Hypertension, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension
- What is being tested?
- Blood sample for the determination of antihypertensives or their metabolites., Questionnaire on sexual activity and Scale on hospital anxiety and depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2022to 7 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with bariatric surgery,
- Patients under guardianship/trusteeship/protection of justice,
- Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
LAZARO Delphine
Toulouse, CHU de Toulouse, 31059
Delphine LAZARO, 5 61 32 30 68 ext. +33, lazaro.d@chu-toulouse.fr
Audrey TOMASIK, 561778597 ext. +33, tomasik.a@chu-toulouse.fr
About this study
Official title: Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study
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.
Read more
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
- Being tested
- Blood sample for the determination of antihypertensives or their metabolites., Questionnaire on sexual activity, Scale on hospital anxiety and depression, Morisky Questionaire
- Keywords
- high blood pressure, antihypertensive drugs, sexual dysfunction
- Medical subject headings
- Hypertension, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 activityBehavioural
Questionnaire on sexual activity in women
Scale on hospital anxiety and depressionBehavioural
Scale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions)
Morisky QuestionaireBehavioural
anti-hypertensive medication compliance questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive women | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 25 months
Secondary outcomes (3)
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".
Measured: 25 months
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)
Measured: 25 months
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;
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start27 Jun 2022
- Primary completion7 Jul 2027 (estimated)
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine LAZARO-VERGE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156385
- Sponsor's protocol ID
- RC31/19/0553
- Acronym
- DYSFHO
- Status last verified
- May 2026
- First submitted
- 15 Oct 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Dysfunction in Hypertensive Women According to Drug Adherence: Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05156385
- Acronym / sponsor ID
- DYSFHO / RC31/19/0553
- Conditions
- Hypertension
- Keywords
- high blood pressure, antihypertensive drugs, sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 7 Jul 2027 (estimated)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with bariatric surgery,
- Patients under guardianship/trusteeship/protection of justice,
- Patients with diagnosed and treated psychosis or depression, - Pregnant or nursing women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample for the determination of antihypertensives or their metabolites.15 ml of Blood sample for the determination of antihypertensives or their metabolites | Biological | Hypertensive women |
| Questionnaire on sexual activityQuestionnaire on sexual activity in women | Behavioural | Hypertensive women |
| Scale on hospital anxiety and depressionScale on hospital anxiety and depression to detect anxious and depressive symptoms (14 questions) | Behavioural | Hypertensive women |
| Morisky Questionaireanti-hypertensive medication compliance questionnaire | Behavioural | Hypertensive women |
Primary outcome
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
3 secondary outcomes
Percentage of patients with a good medication compliance by drug dosages and the Morisky questionnaire
Time frame: 25 months
Number of cases with sexual dysfunction in hypertensive women according to the antihypertensive pharmacological classes used
Time frame: 25 months
Number of cases with sexual dysfunction in hypertensive women according to the number of antihypertensive treatments;
Time frame: 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine LAZARO-VERGE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample for the determination of antihypertensives or their metabolites., Questionnaire on sexual activity and Scale on hospital anxiety and depression in people with Hypertension, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine LAZARO-VERGE (5 61 32 30 68 ext. +33, lazaro.d@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse of sexual dysfunction (time frame: 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.