CHANGES IN THE EFFECTS OF PEYRONIE'S DISEASE AFTER TREATMENT WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM ACCORDING TO MEN WITH PEYRONIE'S DISEASE AND THEIR FEMALE SEXUAL PARTNERS

Collagenase clostridium histolyticum (CCH) demonstrated efficacy for the treatment of Peyronie’s disease (PD) in the double blind, placebo-controlled studies IMPRESS I/II. This study evaluated the effects of CCH treatment on men with Peyronie’s disease (PD), their PD symptoms, and on female bother reported by the men’s female sexual partners (FSPs). In this phase 3, open-label study, men with PD who previously received placebo in IMPRESS I/II were enrolled (n = 189) and received ≤8 injections of CCH (0.58 mg/injection). Assessments included penile curvature deformity (PCD) measures and the PD questionnaire (PDQ). FSPs who chose to participate completed the female sexual function index (FSFI) and the PDQ for FSPs (PDQ-FSP), an investigational questionnaire. From baseline to Week 52, a 36.3% (95% CI 30.9%, 41.6%) improvement in PCD and a 2.4 point (95% CI 1.8, 3.0) improvement in PDQ bother score was observed in the male subjects. The most common AEs reported were penile hematoma, penile pain, and penile swelling; no serious treatment-related AEs were reported. Following CCH treatment of their male partners, the FSPs who participated in the study (n = 30) reported improvement in both their male partner’s PD symptoms and female bother by their partner’s PD (PDQ-FSP mean score reductions of 4.8 and 2.0, respectively). Improvement was also observed on the FSFI scales of desire, arousal, lubrication, orgasm, satisfaction, and pain, as well as the full scale total scores. The proportion of FSPs who reported sexual dysfunction (FSFI total score of <26.55) decreased from 75% at baseline to 33.3% after partner treatment.