Clinical Trial Search

Primary: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study — 214 Subjects

Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 65; 44; 7 mL

Primary: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 7; 8; 126; 0 participants

Primary: Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52 — 26.4; 30.6; 30.6; 15.3…

Primary: Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — -14.7; -13.2 scores on scale — p=0.7921

Primary: Percentage of Responders — 2; 1; 7; 37 Percentage of participants — p=<0.001

Primary: Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale — -16.9; -15.4 Units on a Scale

Primary: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks — -18.3; -21.1; -20.7; -12.8 Units…

Primary: Safety and Tolerability as Measured by Number of Participants With Adverse Events — 323 Participants

Primary: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) — 66; 18 mL

Primary: Minutes From Drug Insertion to Vaginal Delivery — 1595.5; 2127; 1649.5 minutes — p=0.974

Primary: Bleeding on Probing — 53.8; 52.3 Percentage of bleeding sites — p=0.05

Primary: Hypersensitivity to Touch (Tactile) — 42.2; 20.1 Units on a scale — p=0.05

Primary: Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) — 356; 352 Participants — p=0.978

Primary: Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose — 10; 36 Participants — p=<0.001