Clinical Trial Search

Primary: Feasibility - Number of Enrolled Women Participating in All Sessions — 15; 22 Participants — p=0.027

Primary: The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. — 1.0; 0.7 units on a scale

Primary: Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI — 9.98; 7.67 BOLD signal change

Primary: Change From Baseline in the Number of Satisfying Sexual Events — 1.0; 0.6 sexual events

Primary: Satisfying Sexual Event Monthly Change From Baseline at Final Visit — 0.8; 1.4; 1.6 number of events — p=0.0454

Primary: The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE) — 0.2; 0.6; 0.7; 0.8 SSEs — p=<0.05

Primary: Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary. — 1.5; 1.6; 1.6; 1.6 SSEs per week

Primary: Flibanserin: Area Under the Curve; AUC_0-∞ — 2570 ng*h/mL

Primary: Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. — 1.2; 1.5; 0.9 events per month

Primary: 6 Weeks - Total FSFI Score — 26.0; 17.4 score on a scale — p=0.109

Primary: Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary. — 1.4; 1.4; 1.9; 1.1 SSEs per 28 days

Primary: Female Sexual Distress Scale-Revised (FSDS-R) — 22.88; 25.68; 23.02; 23.87 units on a scale

Primary: Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS) — 6.45; 5.98 scores on a scale

Primary: Frequency of Adverse Events — 331; 206; 58; 51 participants with any adverse event

Primary: Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. — 0.54; 0.24; 1.30; 0.77 score on a scale

Primary: Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. — 0.63; 0.21; 1.25; 0.70 score on a scale

Primary: Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period — 2.8; 3.9; 3.2; 1.9 orgasms

Primary: Sexual Function — 24.8; 26.0 score on a scale — p=0.71

Primary: Depressive Symptom Severity — 15.3; 14.1 units on a scale

Primary: Change in 17-OH Pregnenolone — 120; 158; 171; 170 ng/dl — p=>0.8

Primary: Incidence of Endometrial Hyperplasia in Naturally Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD) Not Using Concomitant Estrogen and Progestin, Year 1…

Primary: Female Sexual Function Index (FSFI) — 16.72; 16.88; 22.02; 21.22 score on a scale

Primary: Screen Failure Rate (a Measure of Feasibility) — 36 Participants

Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Scale — 25.9; 14.7; 15.2 units on a scale — p=0.002

Primary: Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire") — 0.64; 0.60; 0.62 units on a scale — p=0.46

Primary: Total Female Sexual Function Index (FSFI) Score — 8.691; 18.783 units on a scale — p=<0.0005

Primary: Change in Median Dyspareunia Pain Scores After 4 Weeks Using Study Drug — -1.5; -3 score on a scale — p=0.08

Primary: Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery. — 0.6; 0.6; 0.6; 0.5 nmol/l — p=0.004

Primary: Clitoral Measurements Using Pelvic MRI — 51.3; 45.1; 29.4; 20.6 millimeters (mm)

Primary: Lean Body Mass — 1.8; 0.8 kilograms — p=0.04