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

NCT06197568 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: GSM-201
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Postmenopausal Symptoms

Keywords

Dyspareunia; Vaginal atrophy

Outcome Measures

Primary Outcomes (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

  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.

  28 days

Secondary Outcomes (9)

• Pharmacokinetics (Cmax)

  24 hours after day 1

• Pharmacokinetics (Tmax)

  24 hours after day 1

• Pharmacokinetics (AUC0-∞)

  24 hours after day 1

• Pharmacokinetics (Cmax)

  24 hours after day 21

• Pharmacokinetics (Tmax)

  24 hours after day 21

Study Arms (5)

Weekly 0.1 μg AZU-101

EXPERIMENTAL

Weekly 0.1 μg vaginal dose of AZU-101

Drug: Lasofoxifene Tartrate (AZU-101)

Weekly 0.5 μg AZU-101

EXPERIMENTAL

Weekly 0.5 μg vaginal dose of AZU-101

Drug: Lasofoxifene Tartrate (AZU-101)

Weekly 1 μg AZU-101

EXPERIMENTAL

Weekly 1 μg vaginal dose of AZU-101

Drug: Lasofoxifene Tartrate (AZU-101)

Twice-weekly 0.1 μg AZU-101

EXPERIMENTAL

Twice-weekly 0.1 μg vaginal dose of AZU-101

Drug: Lasofoxifene Tartrate (AZU-101)

Twice-weekly 0.5 μg AZU-101

EXPERIMENTAL

Twice-weekly 0.5 μg vaginal dose of AZU-101

Drug: Lasofoxifene Tartrate (AZU-101)

Interventions

Lasofoxifene Tartrate (AZU-101) DRUG

0.1 μg vaginal dose of AZU-101 weekly for 4 doses

Also known as: AZU-101

Weekly 0.1 μg AZU-101

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal female subjects between 45 and 65 years old, inclusive (at the time of signing informed consent) with at least:
• 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.
• Vaginal smear with the percentage of superficial cells not exceeding 5%
• In the opinion of the Investigator, the subject will comply with the protocol and has a high probability of completing the study.

You may not qualify if:

• 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
• Evidence of underlying disease during the Screening Visit (performed within 28 days of Day 1) or at admission on Day 1.
• A history or active presence of clinically important medical disease that might confound the study or be detrimental to the subject, 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

Sponsors & Collaborators

• Azure Biotech Inc.: lead

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Howard Levy, MD PhD

CONTACT

(848) 992-5888; hlevy@hlevyconsulting.com

Susan L Levinson, PhD

CONTACT

973-539-4552; slevinson@azurebiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label. Randomization and blinding procedures will not be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be enrolled into five cohorts (n=7/cohort).

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 9, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10