Azure Biotech Inc.
Study Objectives: Primary: • To assess the safety, tolerability, and systemic pharmacokinetics (PK) of AZU-101 Secondary: • To evaluate efficacy of daily vaginal doses of AZU-101 in postmenopausal women on vaginal epithelium
This is a randomized, double-blind, placebo-controlled Phase 2A study of vaginal AZU-101 in healthy postmenopausal female participants with moderate to severe vulvovaginal atrophy (VVA) with no contraindications to selective estrogen receptor modulators (SERMs). AZU-101 is a vaginal formulation of lasofoxifene tartrate, a SERM that has high affinity to both estrogen receptor (ER) alpha (ERα) and ER beta (ERβ). This study plans to evaluate 3 doses of AZU-101 (1, 0.5, and 0.1μg) and placebo. Results of the first cohort (1μg AZU-101) will direct additional dosing cohorts (0.5 and 0.1μg AZU-101).…
Inclusion Criteria: 1. 1\. Postmenopausal female participants between 45 and 60 years old, inclusive (at the time of signing informed consent) with at least: 1. 3 years of spontaneous amenorrhea; or 2. At least 6 months postsurgical bilateral oophorectomy. 2. Pain associated with sexual activity (dyspareunia) 3. Vaginal pH ≥5.0 4. Vaginal smear with the percentage of superficial cells less than 5% 5. In the opinion of the Investigator, the participant will comply with the protocol and has a high probability of completing the study. 6. Normal gynecological examination including Papanico…
1.0 ug for 14 daily doses
Arctuva estimate
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