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EFTA01734942 | EFTA01734953 Contains Nonbinding Recommendations Draft— Notfor Implementation 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 whether women experiencing sexual desire all or most of the time would identify this as a benefit, or whether this could represent a different concern to women. If a sponsor elects to use the FSFI, or a modified FSFI, some potential approaches for doing so are delineated below: (1) A sponsor could develop a new modified FSFI desire domain that includes individual assessment of the components of desire captured on a daily basis with subsequent validation (evaluation of measurement properties). This approach is preferred because it addresses each of the concerns delineated above. (2) A sponsor could use the FSFI desire domain and 28-day recall as currently designed and show that this recall period does not affect conclusions by comparing these results with a subset of subjects who use a shorter recall period (e.g., daily assessment) for the individual desire items. (3) A sponsor could use the FSFI desire domain but remove the multibarreled instructions in the current instrument, and consider including secondary endpoints assessing other components of desire. (4) A sponsor could use the FSFI desire domain and 28-day recall as currently designed without any modifications. This approach carries more risk because the aforementioned issues could make it more difficult to detect or interpret changes in a trial. b. Female Sexual Distress Scale-Revised, Item 1315 Question 13 of the Female Sexual Distress Scale-Revised (FSDS-R) instrument is considered acceptable for measuring bother (a component of distress) related to decreased sexual desire. This question asks "How often did you feel: Bothered by low sexual desire?" Subjects assess their sexual distress over a 7-day recall period and respond on a scale of 0 (never) to 4 (always). c. Other scoring proposals Total scores of the FSFI and FSDS-R are not specific to the outcome measures of interest for the conditions addressed in this guidance. Therefore, the total scores will not be considered acceptable for any labeling claim. E. Trial Endpoints Primary efficacy assessments for adequate and well-controlled trials should be well-defined and reliable to provide a basis for determining whether there is "substantial evidence" to support the claims of effectiveness for a new drug." Endpoint decisions should reflect the primary IS DeRogatis L, Clayton A, et al.. 2008. Validation of the Female Sexual Distress Scale-Revised for Assessing Distress in Women With Hypoactive Sexual Desire Disorder, J Sex Mai, 5:357-364. 16 21 CFR 314.126 9 EFTA_R1_00015167 EFTA01734953 Epstein Web iOS app on the App Store.
March 8, 2026 at 12:51 PM