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This approval was based on two key Phase 3 clinical trials (RECONNECT studies) involving over 1,200 women.[1] Key Approval Details •Approved indication: Hypoactive sexual desire disorder (HSDD) in premenopausal women •Administration: Subcutaneous injection (autoinjector) at least 45 minutes before anticipated sexual activity •Dosage: 1.75 mg per injection, no more than one dose per 24 hours, maximum 8 doses per month •Not approved for: Male sexual dysfunction (though off-label physician use occurs) •Prescription required: Available only through healthcare providers For male patients, PT-141 is used off-label under physician supervision