FP-101 Versus Placebo in the Treatment of Menopausal Vasomotor Symptoms
brief summary
This Phase II proof of concept study is designed to assess the safety and efficacy of FP-101 (60mg b.i.d.), an extended-release oral tablet product, compared to a matching placebo in the treatment of moderate-to-severe hot flashes in peri- and post-menopausal women over a period of 1-week.
detailed description
This randomized, double-blind, parallel-group, placebo-controlled, clinical trial is designed to compare patient-reported changes in Vasomotor Symptoms (VMS) for FP-101 vs. placebo in peri- and post-menopausal women. The study will be run as a fully decentralized clinical trial (DCT), by use of components such as electronic Consent (eConsent), mobile/tele health visits, electronic Patient Reported Outcomes (ePROs), and direct-to-participant shipping of the (investigational medicinal product (IMP). The DCT approach to this study will rely on a digital platform through which subjects can consent, enroll, and interact with the PI and study staff. Proper regulatory framework and technology use will ensure compliance with Good Clinical Practice (GCP), ethics \& legal/regulatory requirements.
Healthy peri- and post-menopausal women (\>45 years of age) suffering from VMS will be recruited if they have \>=7- 8 moderate to severe hot flushes per day at baseline. After meeting all eligibility criteria subjects will be enrolled and start a 1-week run-in period to identify/eliminate placebo responders, as well as to exclude subjects who have difficulty completing the eDiary. Any Adverse Events (AEs) during the run-in period will serve as baseline for the safety assessments at the end of the treatment period.
Eligible subjects will undergo a tele health baseline visit during which the criteria for inclusion in the treatment period will be confirmed. Over a 1-week treatment period, subjects will complete a daily electronic Diary (eDiary) to record any AEs and the frequency and severity of hot flashes during the past 12hr interval. In the morning, subjects will record the number of awakenings during the past night and the number of night sweats.
The PI will conduct an end-of-study visit with each of the subjects randomized to the study medications to review safety and efficacy data, complete a Patient Global Improvement Scale, and clarify any open issues with the subjects.
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official title
Randomized, Double-Blind, Plac.-Controlled Clinical Study to Compare the Efficacy of FP-101 60mg b.i.d. vs. Placebo for the Treatment of Moderate-to-Severe Hot Flashes in Peri- and Post-menopausal Women Over a Period of 1-Week.