A Randomized Controlled Phase 2 Study to Determine Lowest Efficacious Dose of Ovestin in Vulvar and Vaginal Atrophy
Status:
Withdrawn
Trial end date:
2023-05-15
Target enrollment:
Participant gender:
Summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled,
dose-de-escalation study whose purpose is to establish the lowest efficacious dose. The first
40 subjects will be randomized 1:1:1:1 to either 500 mcg, 50 mcg, 10 mcg, or placebo. After
four weeks of dosing with 500 mcg, vaginal pH, vaginal maturation index, and subject's most
bothersome moderate to severe symptom will be assessed; the changes observed will be used as
the benchmark for efficacy throughout the remainder of the study and select the next
dose-level to be investigated. Subjects will be enrolled in small cohorts at various doses
until the lowest effective dose is identified. Then, 1 to 2 doses and a placebo group will be
expanded to enroll 70 subjects per treatment group.