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EFTA01734942 | EFTA01734949 Contains Nonbinding Recommendations Draft — Notfor Implementation 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 in different geographical regions. These differences may affect the generalizability of efficacy data from patients outside the United States to the U.S. population. If the development program includes trials conducted in other geographical regions, these data can be used to support safety. To support efficacy, the trial population should be representative of U.S. women in whom the drug will be intended for use and should reflect the demographic characteristics of the target population with the disorder. Trial subjects should be North American patients who are sexually active and are at least 18 years of age. They should have a documented history of personal distress related to low sexual interest, desire, and/or arousal. Although women who are not in a stable relationship may also experience sexual dysfunction, the FDA recommends that the clinical trials limit enrollment to women who are in a stable relationship. This approach reduces the likelihood of having changes in relationship status during the trials, which could confound the results. Patients should be excluded if the symptoms and associated distress are related to a comorbidity, problems within the relationship, or the effects of a drug or other drug substance. Female sexual dysfunction occurs in adult women. Sponsors can request a full waiver for pediatric studies on the grounds that necessary studies would be impossible because the condition does not exist in the pediatric age group. 2. Eligibility The exclusion criteria (e.g., coexisting medical conditions, concomitant medications, restrictions based on body mass index, history of substance use) should be limited to ensure that the trial population is representative ofNorth American women anticipated to use the drug, if approved. We also encourage sponsors to include patients with a broad range of severity of sexual dysfunction at baseline, provided that the dysfunction causes marked distress (see section III.D.3., Instruments for Measuring Patient-Reported Outcomes, for an assessment of distress). Furthermore, because the eligibility criteria do not need to be identical in all phase 3 trials comprising the clinical program, subsequent trial(s) can have less restrictive entry criteria than the first trial. 3. Menopausal Status Because conditions of low sexual interest, desire, and/or arousal occur in both pre- and postmenopausal women, both groups represent appropriate target populations. Development programs targeting only one of these subgroups should be justified by safety concerns or other clinical grounds. Sponsors can choose to study pre- and postmenopausal women in separate trials or study these populations within the same trial. If studied in the same trial, randomization of subjects should be stratified by menopausal status. Regardless of the approach chosen, dose-finding, safety, and efficacy should be established independently for each of these populations, because the benefitrisk profile may differ and there may be differences in etiologies and treatment responses. Therefore, if both pre- and postmenopausal women are included in the same clinical trial, the trial should be powered adequately to demonstrate statistical and clinical significance for each of these subgroups. 5 EFTA_R1_00015163 EFTA01734949
March 8, 2026 at 12:50 PM