Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women

Conditions

• Vulvo Vaginal Atrophy (VVA)

Eligibility Criteria

Sex

FEMALE

Age

45 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Lasofoxifene Tartrate — DRUG
  1.0 ug for 14 daily doses

Study Details

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

Key Dates

Start date

Jun 1, 2026

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1 microgram dose lasofoxifene tartrate
  Vaginal administration 14 days
• Placebo Comparator: Placebo
  Placebo administered 14 days

Primary Outcome Measure

Number of Participants Who Had Any Serious Adverse Events or Any Treatment Emergent Adverse Events With Severity Greater Than "Moderate" as measured by CTCAE v4.0 [ Time Frame: 15 days ]

Central Contacts

• Howard Levy, MD PhD
  (848) 992-5888
  [email protected]
• Susan L Levinson, PhD
  973-4762430
  [email protected]

Locations (1)

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