Study of Vaginal AZU-101 for Vulvovaginal Atrophy in Postmenopausal Women
This study is testing a new vaginal gel called AZU-101 (a form of lasofoxifene tartrate) for postmenopausal women experiencing vulvovaginal atrophy (VVA). VVA can cause symptoms like pain during sex, vaginal dryness, and itching. Researchers want to see how safe AZU-101 is, how well your body absorbs it, and if it helps improve VVA symptoms. You might be able to join if you are a postmenopausal woman between 45 and 60 years old with pain during sexual activity and a vaginal pH of 5.0 or higher. The study will look at how many participants have side effects and how much of the drug is in their system after 15 days. It will also check for improvements in vaginal health.
- Study design
- This is a randomized, double-blind, placebo-controlled Phase 2A study involving up to 90 postmenopausal women. Participants will receive one of three doses of AZU-101 or a placebo.
- What's involved
- You would take 1.0 ug of Lasofoxifene Tartrate daily for 14 days. Safety and drug levels will be measured at specific times.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured at 15 days, and drug levels will be measured at 24 hours after day 1 and day 14.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
At a glance
Conditions
NCT06197568
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Nucleus Network
Saint Paul, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of Participants Who Had Any Serious Adverse Events or Any Treatment Emergent Adverse Events With Severity Greater Than "Moderate" as measured by CTCAE v4.015 days
Number of participants who had any serious adverse events or any adverse events with severity greater than "moderate," as determined by the Principal Investigator, using the composite safety assessment including clinical laboratory testing (full blood count, biochemistry, coagulation, lipid panel, thyroid hormone, urinalysis), ECG, vital signs, physical examination, transvaginal ultrasound, endometrial biopsy, and self-reporting of adverse events that are determined to be clinically significant.
- Pharmacokinetics (AUC0-∞)24 hours after day 1 and day 14
Area under the concentration versus time curve in pg\*hr/mL
- Pharmacokinetics (Tmax)24 hours after day 1 and day 14
Time to peak plasma concentration in hours
- Pharmacokinetics (Cmax)24 hours after day 1 and day 14
Peak plasma concentration in pg/mL