Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women (NCT06197568) | Clinical Trial Compass
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
United States90 participantsStarted 2026-06-01
Plain-language summary
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
Who can participate
Age range
45 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Exclusion criteria
. 1\. Any contraindication to SERMs
. High risk for breast cancer and women with ductal carcinoma in situ (DCIS)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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