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

NCT06197568 | Recruiting Phase 2 FDA Drug

• 1 other identifier: GSM-201
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vulvo Vaginal Atrophy (VVA)

Keywords

Dyspareunia; Vaginal atrophy; Postmenopausal symptoms; Vaginal dryness or irritation; Painful intercourse

Outcome Measures

Primary Outcomes (4)

• 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.

  15 days

• Pharmacokinetics (AUC0-∞)

  Area under the concentration versus time curve in pg\*hr/mL

  24 hours after day 1 and day 14

• Pharmacokinetics (Tmax)

  Time to peak plasma concentration in hours

  24 hours after day 1 and day 14

• Pharmacokinetics (Cmax)

  Peak plasma concentration in pg/mL

  24 hours after day 1 and day 14

Secondary Outcomes (3)

• Efficacy (Vaginal pH)

  Day 7 and 15

• Efficacy (Maturation index)

  Day 7 and 15

• Efficacy (symptoms)

  15 days

Study Arms (2)

1 microgram dose lasofoxifene tartrate

EXPERIMENTAL

Vaginal administration 14 days

Drug: Lasofoxifene Tartrate

Placebo

PLACEBO COMPARATOR

Placebo administered 14 days

Drug: Lasofoxifene Tartrate

Interventions

Lasofoxifene Tartrate DRUG

1.0 ug for 14 daily doses

Also known as: AZU-101

1 microgram dose lasofoxifene tartrate; Placebo

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Postmenopausal female participants between 45 and 60 years old, inclusive (at the time of signing informed consent) with at least:
• 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:

• \. 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

Sponsors & Collaborators

• Azure Biotech Inc.: lead
• Nucleus Network Ltd: collaborator

Study Sites (1)

Nucleus Network

Saint Paul, Minnesota, 55114, United States

RECRUITING

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

973-4762430; slevinson@azurebiotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blinded, randomized study. Placebo and drug look identical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 9, 2024
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)