in Premenopausal HSDD Patients in Study 1
and Study 2 (MITT* Population)
Study 1 Study 2
VYLEESI
1.75 mg
(N = 313)
Placebo
(N = 314)
VYLEESI
1.75 mg
(N=282)
Placebo
(N= 285)
Mean Baseline (SD)1 2.9 (1.0) 2.8 (0.9) 2.9 (0.9) 2.9 (0.9)
Mean Change from Baseline
(SD)
-0.7 (1.2) -0.4 (1.1) -0.7 (1.1) -0.4 (1.1)
Median Change from Baseline -1 0 -1 0
p- value2 < 0.0001 0.0053
1 FSDS-DAO Q13 score range: 0 to 4, with higher scores indicating greater bother. 2 p-value from unadjusted Wilcoxon rank-sum test.
*MITT: modified intent to treat defined as all patients who were randomized, used at least one dose of the double-blind drug and hadat least one double-blind follow-up visit. However, one VYLEESI patient and two placebo patients in Study 1 and five placebopatients in Study 2 did not have either a baseline or EOS efficacy measurement and change from baseline could not be calculated.
Therefore, N = the number of patients in the MITT population with an eva luable change measurement.
Supplementary analyses were conducted to help interpret clinical meaningfulness of the observed score changefrom baseline to EOS in the FSFI-Desire Domain and FSDS-DAO Q13. These analyses defined responders foreach coprimary efficacy endpoint by anchoring change from baseline to EOS with multiple anchor measures.
Each anchor analysis considered responders to be those who reported experiencing meaningful change at theirEOS visit according to the respective anchor measure.
Because a greater percentage of MITT patients in the VYLEESI group prematurely discontinued the 24-weekdouble-blind treatment period compared to placebo patients (40% vs. 13% for Study 1 and 39% vs. 25% forStudy 2), an exploratory analysis was performed examining the percentages of patients who were able tocomplete the treatment period and improved from baseline. Figure 2 displays the percentages of the MITTpatients in the two Phase 3 trials who completed the 24-week double-blind treatment period and achievedvarious levels of increase in the FSFI-Desire Domain Score from baseline (higher scores indicate increasedsexual desire). Figure 3 displays the percentages of the MITT patients in the two clinical trials who completedthe 24-week double-blind treatment period and achieved various levels of reduction in the FSDS-DAO Q13score from baseline (higher scores indicate greater reduction in distress).
Figure 2: Percent of Patients (MITT Population) who Completed the 24-Week Double-Blind TreatmentPeriod and Achieved Various Levels of Increases in the FSFI-Desire Domain ScorePatients who did not complete the double-blind treatment period or were missing baseline scores are not considered to haveexperienced an increase in FSFI-Desire Domain score at the end of the double-blind treatment period.
Responder threshold: at least 1.2-point increase from baseline in FSFI-Desire Domain score. The threshold was defined for thesestudies by anchoring change from baseline to end of treatment with multiple anchor measures.
Figure 3: Percent of Patients (MITT Population) who Completed the 24-Week Double-Blind TreatmentPeriod and Achieved Various Levels of Reductions in the FSDS-DAO Q13 ScorePatients who did not complete the double-blind treatment period or were missing change from baseline scores are not considered tohave experienced a decrease in FSDS-DAO Q13 score at the end of the double-blind treatment period.
Responder threshold: at least 1-point decrease from baseline in the FSDS |
