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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Vulvo Vaginal Atrophy (VVA)

In brief

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 facts

Study ID

NCT06197568

Run by

Azure Biotech Inc.

People needed

90

Starts

2026-06-01

Expected to finish

2027-06-30

Last updated by the study team

2026-05-22

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify 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
• 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.

You may not qualify 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
• 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

Where it is running

• Nucleus Network — Saint Paul, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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