Not Yet RecruitingPhase 1/2

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

35 participantsStarted 2026-05-01

Plain-language summary

Study Objectives: Primary ° To evaluate the safety and tolerability of multiple vaginal doses of AZU-101 at 3 dose levels in postmenopausal women Secondary * To assess systemic pharmacokinetics (PK) of AZU-101 * To assess the efficacy of multiple vaginal doses of AZU-101 at 3 dose levels in postmenopausal women

Who can participate

Age range45 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Postmenopausal female subjects between 45 and 65 years old, inclusive (at the time of signing informed consent) with at least:
✓. 12 months of spontaneous amenorrhea; or
✓. At least 6 weeks postsurgical bilateral oophorectomy.
✓. Have self-identified at least one moderate to severe vaginal symptom that is most bothersome to her:
✓. Pain associated with sexual activity (dyspareunia)
✓. Vaginal dryness
✓. Vaginal irritation/itching
✓. Vaginal pH ≥5.

Exclusion criteria

✕. Any contraindication to SERMs
✕. 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 4 weeks before Screening Visit
✕. Vaginal hormone products (rings, creams, gels) within 4 weeks 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 medication, herbal product or nutritional supplement known or suspected to interact with AZU-101 within 2 weeks prior to Screening Visit

What they're measuring

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

Timeframe: 28 days

Trial details

NCT IDNCT06197568

SponsorAzure Biotech Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Howard Levy, MD PhD

(848) 992-5888 hlevy@hlevyconsulting.com

View on ClinicalTrials.gov More Postmenopausal Symptoms trials