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New treatment option for Vulvo Vaginal Atrophy (VVA)
Official title Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
ClinicalTrials.gov ID: NCT06197568
What this study is testing
What is Lasofoxifene Tartrate?
Lasofoxifene Tartrate is an investigational medicine, given as an once-daily, being studied as a potential treatment for vulvo vaginal atrophy (vva).
Also referred to as AZU-101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 60, women only
You may be able to join if
- 1\. Postmenopausal female participants between 45 and 60 years old, inclusive (at the time of signing informed consent) with at least:
- 3 years of spontaneous amenorrhea; or
- At least 6 months postsurgical bilateral oophorectomy.
- Pain associated with sexual activity (dyspareunia)
- Vaginal pH ≥5.0
You likely can't join if
- 1\. Any contraindication to SERMs
- High risk for breast cancer and women with ductal carcinoma in situ (DCIS)
- A history of liver cancer
- A history of lung cancer
- Conditions resulting in an increased risk of hypercoagulability, including immobility and strong family history of hypercoagulability
- Documented coronary artery disease or at increased risk for major coronary events
See the full eligibility criteria
Who can join
- 1\. Postmenopausal female participants between 45 and 60 years old, inclusive (at the time of signing informed consent) with at least:
- 3 years of spontaneous amenorrhea; or
- At least 6 months postsurgical bilateral oophorectomy.
- Pain associated with sexual activity (dyspareunia)
- Vaginal pH ≥5.0
- Vaginal smear with the percentage of superficial cells less than 5%
- In the opinion of the Investigator, the participant will comply with the protocol and has a high probability of completing the study.
- Normal gynecological examination including Papanicolaou (Pap) smear (required for all participants, including those with prior hysterectomy)
- Good general health as evaluated by physical exam and lab assessments
- Agrees to not take any OTC medication, herbal product or nutritional supplement containing soy or plant extracts during the study conduct until final visit
- Agrees to not use any vaginal lubricants.
- If taking statin as a concomitant medication, must be on a stable dose for 3 months without plan to change during the course of the study and through study completion
- Agree to use a condom during sexual intercourse with a male partner during the study and for 1 month after the last dose.
What rules you out
- 1\. Any contraindication to SERMs
- High risk for breast cancer and women with ductal carcinoma in situ (DCIS)
- A history of liver cancer
- A history of lung cancer
- Conditions resulting in an increased risk of hypercoagulability, including immobility and strong family history of hypercoagulability
- Documented coronary artery disease or at increased risk for major coronary events
- History of developing hypertriglyceridemia resulting from previous estrogen product treatment
- History of symptomatic cataracts
- History of endometrial polyps or abnormal endometrial findings on transvaginal ultrasound evaluation
- 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 3 months before Screening Visit
- Vaginal hormone products (rings, creams, gels) within 3 months 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 OTC medication, herbal product or nutritional supplement containing soy or plant extracts within 2 weeks prior to Screening Visit
- A history or active presence of clinically important medical disease that might confound the study or be detrimental to the participant, 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 5 mm
- A body mass index (BMI) \ 34 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
- Daily use of cigarettes or use of any electronic cigarettes
- Use of an investigational drug or biologic within 60 days before administration of the first dose of study drug. Participants must agree not to participate in another research study of an investigational drug or device...
- 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...
- 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...
- Hematocrit \ 45%
- Serum creatinine \>1.5 mg/dL.
- Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) \>1.5 times the ULN for the laboratory used
- Fasting total cholesterol \>300 mg/dL (7.77 mmol/L) or triglycerides \>300 mg/dL (3.39 mmol/L)
- Positive laboratory finding for Factor V Leiden mutation
- Fasting glucose \>125 mg/dL
- Uncontrolled hypertension (participants 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
- Hypotension; participants 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, hepatitis C, or active STD
- Untreated vaginal or urinary tract infection, or chronic urinary tract infections requiring repeated antibiotic treatment.
- Serum estradiol ≥20 pg/mL (≥73 pmol/L) at screening
- Thyroid-stimulating hormone (TSH) \ 8.0 mIU/L
- History of lichen sclerosis vulvae
- Serum follicle-stimulating hormone (FSH) ≤30 IU/L
- Poor venous access
The study team makes the final eligibility decision.
Where it's taking place
- Saint Paul, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Paul, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.