MenopauseEXIMeNCT03558451
Multicentre Clinical Trial. Project EXIMe
A study testing Complex intervention in sexual health in people with Menopause, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial summary
Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Complex intervention in sexual health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jul 2017to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women aged between 45-65 years with Genitourinary Syndrome of Menopause
Who cannot join
- women who present pathologies that lead to an alteration of sexual desire
- women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy
- women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the Genitourinary Syndrome of Menopause
- women who could not read or write, and not understand the spanish language.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe
Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid.
Read the detailed description
Genitourinary Syndrome of Menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. Those women with an active sexual life have fewer symptoms associated with this syndrome. Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid. Population: women aged between 45-65 years with Genitourinary Syndrome of Menopause attending to the midwife consultation. N= 250 (125 women in each group) will be included by midwifes in the Primary Health Care consultations in the Community of Madrid. Control group: women will receive the usual assistance.
Experimental group: in addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. Variables: Main-Quality of life in menopause (measured with the Cervantes Short-Form Scale). Secondary- sociodemographic variables, sexual history and variables related to the Genitourinary Syndrome of Menopause. Analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. To explain the factors associated with a higher quality of life, a linear regression model would be fitted.
- Conditions
- Menopause
- Being tested
- Complex intervention in sexual health, Usual care
- Keywords
- Primary health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex intervention in sexual healthOther
Also called Usual care
EXIMe is a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used.
Usual careOther
Also called Women will receive the usual assistance
According to available protocols applicable to the patient and the health service standardized portfolio
| Study group | Role | What they receive |
|---|---|---|
| EXIMe intervention | Experimental | In addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. Receives: Other: Complex intervention in sexual health; Other: Usual care |
| Usual care | Active comparator | Usual care according to available protocols applicable to the women and the health service standardized portfolio Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main-Quality of life in menopause
Main-Quality of life in menopause measured with "Cervantes Short-Form Scale" (20 -100 points)
Measured: Change from baseline Quality of life at six months
Secondary outcomes (4)
Sexual function
Sexual function: measured with Questionnaire "Health and female sexual dysfunction in primary care"
Measured: Change from baseline at six months
vaginal pH
vaginal pH
Measured: Change from baseline at six months
Oxford scale
Oxford scale: pelvic floor muscle response
Measured: Change from baseline at six months
Urine sediment
Urine sediment
Measured: Change from baseline at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start10 Jul 2017
- Primary completion15 Oct 2018
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid
- Responsible party
- Sponsor
- Investigators
- Lucia Martinez-Villarejo, Midwife, Principal investigator, Gerencia de Atención Primaria, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558451
- Sponsor's protocol ID
- CCI 24/16
- Acronym
- EXIMe
- Status last verified
- Aug 2019
- First submitted
- 5 Feb 2018
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe
- ClinicalTrials.gov ID
- NCT03558451
- Acronym / sponsor ID
- EXIMe / CCI 24/16
- Conditions
- Menopause
- Keywords
- Primary health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 15 Jun 2018 (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.
Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid.
Detailed description
Genitourinary Syndrome of Menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. Those women with an active sexual life have fewer symptoms associated with this syndrome. Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid. Population: women aged between 45-65 years with Genitourinary Syndrome of Menopause attending to the midwife consultation. N= 250 (125 women in each group) will be included by midwifes in the Primary Health Care consultations in the Community of Madrid. Control group: women will receive the usual assistance.
Experimental group: in addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. Variables: Main-Quality of life in menopause (measured with the Cervantes Short-Form Scale). Secondary- sociodemographic variables, sexual history and variables related to the Genitourinary Syndrome of Menopause. Analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. To explain the factors associated with a higher quality of life, a linear regression model would be fitted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid
| Arm | Type | Receives |
|---|---|---|
| EXIMe intervention | Experimental | Other: Complex intervention in sexual health, Other: Usual careIn addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. |
| Usual care | Active comparator | Other: Usual careUsual care according to available protocols applicable to the women and the health service standardized portfolio |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women aged between 45-65 years with Genitourinary Syndrome of Menopause
Key exclusion criteria (4 listed)
- women who present pathologies that lead to an alteration of sexual desire
- women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy
- women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the Genitourinary Syndrome of Menopause
- women who could not read or write, and not understand the spanish language.
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 |
|---|---|---|
| Complex intervention in sexual healthAlso: Usual careEXIMe is a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. | Other | EXIMe intervention |
| Usual careAlso: Women will receive the usual assistanceAccording to available protocols applicable to the patient and the health service standardized portfolio | Other | EXIMe intervention, Usual care |
Primary outcome
Main-Quality of life in menopause
Time frame: Change from baseline Quality of life at six months
Main-Quality of life in menopause measured with "Cervantes Short-Form Scale" (20 -100 points)
4 secondary outcomes
Sexual function
Time frame: Change from baseline at six months
vaginal pH
Time frame: Change from baseline at six months
Oxford scale
Time frame: Change from baseline at six months
Urine sediment
Time frame: Change from baseline at six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- 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. This study is not recruiting at the moment.
Lucia Martinez-Villarejo, Midwife principal investigator
Gerencia de Atención Primaria, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex intervention in sexual health in people with Menopause, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 11 Aug 2022. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main-Quality of life in menopause (time frame: Change from baseline Quality of life at six 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 11 Aug 2022.