Open-Label Study of Vaginal AZU-101 in Postmenopausal Women

Launched by AZURE BIOTECH INC. · Dec 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AZU-101 to see if it is safe and effective for treating symptoms that some postmenopausal women experience. These symptoms can include pain during sexual activity, vaginal dryness, and irritation. The trial will involve women between the ages of 45 and 65 who have been postmenopausal for at least a year or have had certain surgeries. Participants will need to have at least one bothersome vaginal symptom and meet specific health requirements to be eligible.

During the trial, participants will receive different doses of AZU-101 and will be monitored for any side effects or issues. This means that if you join the study, you can expect to regularly check in with the research team, who will keep track of how you're feeling and any changes in your symptoms. It's important to note that this trial is not yet recruiting participants, so you will need to wait for it to start if you are interested in taking part.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• 1. Postmenopausal female subjects between 45 and 65 years old, inclusive (at the time of signing informed consent) with at least:
• • 1. 12 months of spontaneous amenorrhea; or
• • 2. At least 6 weeks postsurgical bilateral oophorectomy.
• 2. Have self-identified at least one moderate to severe vaginal symptom that is most bothersome to her:
• • 1. Pain associated with sexual activity (dyspareunia)
• • 2. Vaginal dryness
• • 3. Vaginal irritation/itching
• • 3. Vaginal pH ≥5.
• • 4. Vaginal smear with the percentage of superficial cells not exceeding 5%
• • 5. In the opinion of the Investigator, the subject will comply with the protocol and has a high probability of completing the study.
• Exclusion Criteria:
• • 1. Any contraindication to SERMs
• 2. Use of any of the following:
• • 1. Oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 3 months before Screening Visit
• • 2. Transdermal hormone products within 4 weeks before Screening Visit
• • 3. Vaginal hormone products (rings, creams, gels) within 4 weeks before Screening Visit
• • 4. Intrauterine progestins within 8 weeks before Screening Visit
• • 5. Progestin implants/injectables or estrogen pellets/injectables within 6 months before Screening Visit
• • 6. Any medication, herbal product or nutritional supplement known or suspected to interact with AZU-101 within 2 weeks prior to Screening Visit
• • 3. Evidence of underlying disease during the Screening Visit (performed within 28 days of Day 1) or at admission on Day 1.
• 4. 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:
• • 1. Endometrial hyperplasia
• • 2. Undiagnosed vaginal bleeding
• • 3. History of a chronic liver or kidney dysfunction/disorder (e.g., hepatitis C or chronic renal failure)
• • 4. Thrombophlebitis, thrombosis, or thromboembolic disorders
• • 5. Cerebrovascular accident, stroke, or transient ischemic attack
• • 6. Myocardial infarction or ischemic heart disease
• • 7. 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
• • 8. History of estrogen dependent neoplasia, breast cancer, melanoma, or any gynecologic cancer, at any time
• • 9. Endocrine disease (except for controlled hypothyroidism or controlled non-insulin dependent diabetes mellitus)
• • 10. Known breast cancer gene (BRCA) mutation associated with increased risk of neoplasia
• • 5. TVUS of the endometrium at Screening with a double-wall thickness measurement greater than 4 mm
• • 6. Abnormal endometrial biopsy in non-hysterectomized women
• • 7. A body mass index (BMI) \<18 and \>38 kg/m2
• • 8. History of known alcohol or drug abuse within 1 year of the Screening Visit
• • 9. Positive urine drug or alcohol screen at Screening Visit
• • 10. Use of 15 or more cigarettes per day or current use of any electronic cigarettes
• • 11. Use of an investigational drug or biologic within 60 days before administration of the first dose of study drug
• 12. Any clinically important abnormalities on Screening physical examination, assessments, ECG, or laboratory tests, including but not limited to:
• • 1. 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.
• • 2. 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.
• • 3. Hematocrit \<35% or \>45%
• • 4. Serum creatinine \>15% of the upper limit of normal (ULN) for the laboratory used.
• • 5. Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) \>1.5 times the ULN for the laboratory used
• • 6. Fasting total cholesterol greater than 300 mg/dL (7.77 mmol/L) or triglycerides greater than 300 mg/dL (3.39 mmol/L)
• • 7. Positive laboratory finding for Factor V Leiden mutation
• • 8. Fasting glucose \>125 mg/dL
• • 9. 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
• • 10. Uncontrolled hypotension; subjects with sitting BP \<95 mmHg systolic or \<65 mmHg diastolic
• • 11. A clinically significant abnormal 12-lead ECG (e.g., showing previous myocardial infarction or other findings suggestive of ischemia)
• • 12. Positive human immunodeficiency virus (HIV), hepatitis B, or hepatitis C