Status:
NOT_YET_RECRUITING
Open-Label Study of Vaginal AZU-101 in Postmenopausal Women
Lead Sponsor:
Azure Biotech Inc.
Conditions:
Postmenopausal Symptoms
Eligibility:
FEMALE
45-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Study Objectives: Primary ° To evaluate the safety and tolerability of multiple vaginal doses of AZU-101 at 3 dose levels in postmenopausal women Secondary * To assess systemic pharmacokinetics (P...
Detailed Description
This is an open-label Phase 1b/2a study to evaluate the safety, pharmacokinetics (PK), and efficacy of vaginal AZU-101 in healthy postmenopausal female subjects over a period of 28 days. AZU-101 is a ...
Eligibility Criteria
Inclusion
- Postmenopausal female subjects between 45 and 65 years old, inclusive (at the time of signing informed consent) with at least:
- 12 months of spontaneous amenorrhea; or
- At least 6 weeks postsurgical bilateral oophorectomy.
- Have self-identified at least one moderate to severe vaginal symptom that is most bothersome to her:
- Pain associated with sexual activity (dyspareunia)
- Vaginal dryness
- Vaginal irritation/itching
- Vaginal pH ≥5.
- Vaginal smear with the percentage of superficial cells not exceeding 5%
- In the opinion of the Investigator, the subject will comply with the protocol and has a high probability of completing the study.
Exclusion
- Any contraindication to SERMs
- Use of any of the following:
- Oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 3 months before Screening Visit
- Transdermal hormone products within 4 weeks before Screening Visit
- Vaginal hormone products (rings, creams, gels) within 4 weeks before Screening Visit
- Intrauterine progestins within 8 weeks before Screening Visit
- Progestin implants/injectables or estrogen pellets/injectables within 6 months before Screening Visit
- Any medication, herbal product or nutritional supplement known or suspected to interact with AZU-101 within 2 weeks prior to Screening Visit
- Evidence of underlying disease during the Screening Visit (performed within 28 days of Day 1) or at admission on Day 1.
- A history or active presence of clinically important medical disease that might confound the study or be detrimental to the subject, including but not limited to:
- Endometrial hyperplasia
- Undiagnosed vaginal bleeding
- History of a chronic liver or kidney dysfunction/disorder (e.g., hepatitis C or chronic renal failure)
- Thrombophlebitis, thrombosis, or thromboembolic disorders
- Cerebrovascular accident, stroke, or transient ischemic attack
- Myocardial infarction or ischemic heart disease
- Malignancy or treatment for malignancy, within the previous 5 years, with the exception of basal cell carcinoma of the skin or squamous cell carcinoma of the skin
- History of estrogen dependent neoplasia, breast cancer, melanoma, or any gynecologic cancer, at any time
- Endocrine disease (except for controlled hypothyroidism or controlled non-insulin dependent diabetes mellitus)
- Known breast cancer gene (BRCA) mutation associated with increased risk of neoplasia
- TVUS of the endometrium at Screening with a double-wall thickness measurement greater than 4 mm
- Abnormal endometrial biopsy in non-hysterectomized women
- A body mass index (BMI) \<18 and \>38 kg/m2
- History of known alcohol or drug abuse within 1 year of the Screening Visit
- Positive urine drug or alcohol screen at Screening Visit
- Use of 15 or more cigarettes per day or current use of any electronic cigarettes
- Use of an investigational drug or biologic within 60 days before administration of the first dose of study drug
- Any clinically important abnormalities on Screening physical examination, assessments, ECG, or laboratory tests, including but not limited to:
- Unresolved cervical cytologic smear report of atypical glandular cells of undetermined significance (AGUS) or atypical squamous cells of undetermined significance (ASCUS). Cervical cytologic smear report of low-grade squamous intraepithelial lesion (SIL) or greater, cervical intraepithelial neoplasia (CIN) grade 1 or greater, or any reported dysplasia; Subjects with ASCUS are eligible only if high risk human papilloma virus (HPV) result is negative or she has a history of vaccination against HPV.
- Unresolved findings suspicious for malignancy on the breast exam; incomplete mammogram result (Breast Imaging Reporting and Data System \[BI-RADS\] category 0) or unresolved findings suggestive of malignant changes or findings requiring short interval follow-up on the pre-study mammogram (subjects must have mammography result of BI-RADS category 1 or 2 to enroll). Mammogram performed within 9 months prior to Screening Visit with documentation available may be used to evaluate study eligibility. The site must obtain a copy of the official report for the subject's study file, and it must be verified that the mammogram itself is available if needed for additional assessment.
- Hematocrit \<35% or \>45%
- Serum creatinine \>15% of the upper limit of normal (ULN) for the laboratory used.
- Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) \>1.5 times the ULN for the laboratory used
- Fasting total cholesterol greater than 300 mg/dL (7.77 mmol/L) or triglycerides greater than 300 mg/dL (3.39 mmol/L)
- Positive laboratory finding for Factor V Leiden mutation
- Fasting glucose \>125 mg/dL
- Uncontrolled hypertension (subjects with sitting BP \>139 mmHg systolic or \>89 mmHg diastolic) and may not be using more than 2 antihypertensive medications for the treatment of hypertension
- Uncontrolled hypotension; subjects with sitting BP \<95 mmHg systolic or \<65 mmHg diastolic
- A clinically significant abnormal 12-lead ECG (e.g., showing previous myocardial infarction or other findings suggestive of ischemia)
- Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06197568
Start Date
May 1 2026
End Date
June 30 2027
Last Update
October 15 2025
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