What the research shows
Two double-blind phase 3 trials randomly assigned 1,267 premenopausal women to bremelanotide or placebo. Over 24 weeks, participants receiving bremelanotide reported higher desire scores and less distress related to low desire than participants receiving placebo. Nausea, flushing and headache were more frequent with bremelanotide. The questionnaires measured symptoms in the enrolled group. Read the two RECONNECT trials.
The U.S. prescribing information describes the patient population, formulation and limits of use. Read the Vyleesi label.
Documented formats
Vyleesi contains bremelanotide acetate in a sterile, clear solution. The label identifies a prefilled, single-use autoinjector. A research sample bearing the name PT-141 alone does not establish that finished formulation.
Testing and purity
Distinguish the mass of the acetate salt from the equivalent mass of bremelanotide. The label reports both for the same unit, and the two numbers have different meanings.
How to read a batch reportQuestions about PT-141
What does acquired mean in this diagnosis?
It means the difficulty developed after a period in which the person had no problem with sexual desire.
How did investigators evaluate distress?
Participants answered a questionnaire item about being bothered by low desire. Researchers compared changes in that score between the active and placebo groups.