Last reviewed · How we verify
NCT07090239: f-FSDS-R
French Translation of The Female Sexual Distress Scale-Revised
trial in The Translation of a Screening Tool in 60 participants. Participants enrolled and being followed up; not accepting new ones.
28 February 2026
Quick facts
| Lead sponsor | University Hospital, Brest |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 1 March 2025 |
| Primary completion | 28 February 2026 |
| Estimated completion | 28 February 2026 |
| Sites | 1 location across France |
Conditions studied
- The Translation of a Screening Tool — all drugs for The Translation of a Screening Tool →
Sponsor
University Hospital, Brest
Who can join
Adults 18 to 75, female only, with The Translation of a Screening Tool. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Two independent teams (Brest and Nice) each produce a forward translation from English to French. The translations are compared, and discrepancies are discussed with the translation coordinator, the second translator, and the scientific lead to produce a unified preliminary French version (Version 1), including the response options. Version 1 is then back-translated into English by an English-speaking linguist and a French physician whose native language is English, without access to the original questionnaire, in order to detect potential translation issues. The team then holds a discussion to compare the original English version, the French Version 1, and the back-translations, resulting in the development of Version 2. Version 2 is tested with a representative sample of patients using a paper questionnaire, which includes two follow-up questions after each item to assess comprehension and identify potential difficulties. The team analyzes the responses, and if comprehension issues are identified, they organize further discussions with the translators and back-translators to revise the items concerned. The revised items are then re-tested with patients, including those who have and have not reported difficulties, to ensure that the final version is clear and understandable for all. the investigators conduct prospective recruitment after verifying the inclusion and exclusion criteria. Inclusion criteria: Adult patient Affiliation with a social security scheme Exclusion criteria: Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate Patients with difficulties understanding the French language Patients consulting in the adult or gynecological emergency department, or accompanying another person, are informed about the possibility of completing a questionnaire. The participants informed that their data will be recorded for the purpose of practice evaluation and results analysis in an anonymous and confidential manner, using the information sheet provided for the study. The participants free to refuse participation without any impact on their care. Patients receive complete and clear information regarding the objectives of the study, their right to refuse participation, and their right to withdraw at any time. All this information appears on the information and non-opposition form provided to each patient. Participation is noted in the patient's medical record. Administration procedures: The questionnaire is distributed in the waiting area and is self-administered by the patient. Once consent is given, the patient completes the questionnaire independently. Follow-up: The estimated participation time is approximately 10 minutes, corresponding to the time required to complete the questionnaire. Patients may be contacted again if necessary to re-test reformulated items, including those who reported comprehension difficulties and others who did not. The inclusion period lasts 6 months. The individual participation time is 10 minutes. The total duration of the prospective study (inclusion + follow-up) is 8 months. The overall study timeline (including data entry and management of non-opposition forms) is 12 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07090239
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07090239 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
- Last refreshed: 2 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07090239.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing