Female Genital MutilationNCT07027696
Sexual Health of Women With Genital Mutilation Seen at the Saint-Denis Women's Center
An observational study of Female Genital Mutilation and Sexual Dysfunctions, Psychological, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This study looks at the sexual health of women who have experienced female genital mutilation (FGM) and who are receiving care at the Women's Center at Saint-Denis Hospital. It aims to better understand their sexual experiences, including the impact of past violence and trauma, and to explore how multidisciplinary… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Female Genital Mutilation, Sexual Dysfunctions, Psychological, Sexual Health
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- 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 15 years and older
- Women only
- Child, Adult, Older adult
Study population: The study population consists of adult women who have experienced female genital mutilation (FGM) or are considered to be excised, and who are consulting at the Maison des Femmes (Women's House) of the Saint-Denis Hospital in France. These women are engaged in a multidisciplinary care pathway addressing the consequences of FGM. Most are migrants who have faced various forms of violence, either in their country of origin or during their migration journey.
Who may be able to join
- Women with female genital mutilation (FGM), or considered to be excised, consulting at the Maison des Femmes (Women's House) at Saint-Denis Hospital.
- Women enrolled in the multidisciplinary care pathway for FGM.
Who cannot join
- Women under the age of 15.
Trial locations and contacts
1 site in 1 country.
About this study
This study looks at the sexual health of women who have experienced female genital mutilation (FGM) and who are receiving care at the Women's Center at Saint-Denis Hospital. It aims to better understand their sexual experiences, including the impact of past violence and trauma, and to explore how multidisciplinary care (such as psychological and sexological support) can help. The study also looks at what women expect from their care and how they feel about surgical or other types of support.
- Conditions
- Female Genital Mutilation, Sexual Dysfunctions, Psychological, Sexual Health, Violence Against Women, Post-Traumatic Stress Disorders, Acculturation
- Medical subject headings
- Sexual Dysfunctions, Psychological, Stress Disorders, Post-Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the sexual function profile of women with female genital mutilation (FGM) during consensual sexual activity, using a structured clinical sexological evaluation that accounts for histories of violence.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital MutilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027696
- Sponsor's protocol ID
- 0061_MAISON DES FEMMES
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Health of Women With Genital Mutilation Seen at the Saint-Denis Women's Center
- ClinicalTrials.gov ID
- NCT07027696
- Acronym / sponsor ID
- 0061_MAISON DES FEMMES
- Conditions
- Female Genital Mutilation, Sexual Dysfunctions, Psychological, Sexual Health, Violence Against Women, Post-Traumatic Stress Disorders, Acculturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jun 2025 (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.
This study looks at the sexual health of women who have experienced female genital mutilation (FGM) and who are receiving care at the Women's Center at Saint-Denis Hospital. It aims to better understand their sexual experiences, including the impact of past violence and trauma, and to explore how multidisciplinary care (such as psychological and sexological support) can help. The study also looks at what women expect from their care and how they feel about surgical or other types of support.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of adult women who have experienced female genital mutilation (FGM) or are considered to be excised, and who are consulting at the Maison des Femmes (Women's House) of the Saint-Denis Hospital in France. These women are engaged in a multidisciplinary care pathway addressing the consequences of FGM. Most are migrants who have faced various forms of violence, either in their country of origin or during their migration journey.
Key inclusion criteria (2 listed)
- Women with female genital mutilation (FGM), or considered to be excised, consulting at the Maison des Femmes (Women's House) at Saint-Denis Hospital.
- Women enrolled in the multidisciplinary care pathway for FGM.
Key exclusion criteria (1 listed)
- Women under the age of 15.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the sexual function profile of women with female genital mutilation (FGM) during consensual sexual activity, using a structured clinical sexological evaluation that accounts for histories of violence.
Time frame: 6 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 18 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Genital Mutilation and Sexual Dysfunctions, Psychological, run by Centre Hospitalier de Saint-Denis 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 2 inclusion and 1 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 18 Jun 2025. 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?
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?
Assessment of the sexual function profile of women with female genital mutilation (FGM) during consensual sexual activity, using a structured clinical sexological evaluation that accounts for histories of violence. (time frame: 6 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 18 Jun 2025.