9 to 56 yearsold); the mean duration in a monogamous relationship was 12 years, and the mean duration of HSDD wasapproximately 4 years. Across the two trials, the median number of VYLEESI injections was 10 in the 24-weekdouble-blind treatment period and 12 during the uncontrolled open-label extension. Most patients usedVYLEESI two to three times per month and no more than once a week.
Study 1 and Study 2 had the following co-primary efficacy endpoints:
• Change from baseline to end of study (EOS) in the Desire domain from the Female Sexual Function Index(FSFI) (Questions 1 and 2). Question 1 asks patients “Over the past 4 weeks, how often did you feel sexualdesire or interest?”, with responses ranging from 1 (almost never or never) to 5 (almost always or always).
Question 2 asks patients “Over the past 4 weeks, how would you rate your level (degree) of sexual desire orinterest?”, with responses ranging from 1 (very low or none at all) to 5 (very high). The FSFI Desiredomain score was calculated by adding the patient’s responses to these two questions then multiplying thatsum by 0.6. The FSFI Desire Domain score ranged from 1.2 to 6. An increase in the FSFI Desire domainscore over time denotes improvement in sexual desire.
• Change from baseline to EOS in the score for feeling bothered by low sexual desire as measured by theFemale Sexual Distress Scale – Desire/Arousal/Orgasm Question 13 (FSDS-DAO Q13). This question asks
patients, “How often did you feel: Bothered by low sexual desire?” Patients assessed their sexual distressover a 30-day recall period and responded on a scale of 0 (never) to 4 (always). A decrease in the FSDSDAOQ13 score over time denotes improvement in the level of distress associated with low sexual desire.
EOS is defined as the patient’s last study visit during the double-blind treatment period. For patients whocompleted the double-blind treatment period, the EOS visit occurred at Week 24.
Efficacy results for these co-primary endpoints from Study 1 and Study 2 are summarized in Table 2 and Table3. In both studies, VYLEESI showed a statistically significant increase in the FSFI Desire Domain score and astatistically significant decrease in the FSDS-DAO Q13 score from baseline to the EOS visit compared toplacebo. The magnitude of the treatment differences was similar in both studies.
Table 2: Efficacy Results for the FSFI-Desire Domain Score in Premenopausal HSDD Patients in Study
1 and Study 2 (MITT* Population)
Study 1 Study 2
VYLEESI
1.75 mg
(N= 313)
Placebo
(N= 315)
VYLEESI
1.75 mg
(N= 282)
Placebo
(N=288)
Mean Baseline (SD)1 2.1 (0.9) 2.0 (0.8) 2.0 (0.8) 2.1 (0.8)
Mean Change from Baseline (SD) 0.5 (1.1) 0.2 (1.0) 0.6 (1.0) 0.2 (0.9)
Median Change from Baseline 0.6 0 0.6 0
p-value2 0.0002 < 0.0001
1 FSFI Desire score range: 1.2 to 6.0, with higher scores indicating greater desire. 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 double-blind study drug, andhad at least one double-blind follow-up visit. However, one VYLEESI patient and one placebo patient in Study 1 and two placebopatients in Study 2 did not have either a baseline or EOS efficacy measurement and change from baseline could not becalculated. Therefore, N = the number of patients in the MITT population with an eva luable change measurement.
Table 3: Efficacy Results for the FSDS-DAO Q13 Score |
