A study to find out if Myrecil® topical cream can help manage genitourinary symptoms in menopausal women.

A Randomized, Double Blind, Placebo-Controlled Study to evaluate the efficacy and safety of Myrecil® in women with Genitourinary Syndrome of Menopause

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000510549

Enrollment

Registered

2024-04-24

Start date

2024-05-29

Completion date

2024-07-29

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Menopause is a regular mid-life event associated with the reduced functioning of ovaries subsequently resulting in low endogenous estrogen levels. Approximately 50% of menopausal women experience a chronic and progressive condition known as genitourinary syndrome of menopause (GSM) which is detrimental to post-menopausal women’s health. Researching a novel moisturizer treatment for GSM can potentially benefit many women who are suffering from various symptoms like dryness, itching, burning, and painful intercourse. The purpose of this study is to evaluate the effectiveness and safety of Myrecil® relative to placebo in postmenopausal females with GSM. The study is designed to test the hypothesis that Myrecil® will improve the symptoms of GSM, have a beneficial effect on vaginal health and improve the patients’ quality of life.

Interventions

Myrecil® 3% , vaginal cream, one 2mg application daily (in the evening) for 56 days. Compliance will be assessed at Day 14 and at each in-clinic visit (D28 and D56) during the treatment period. In addition, at Day 28 and Day 56 the Investigator or designee will also question the participant about whether she has complied with the study dosing regimen and will review the participant completed daily dosing study diary.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

50 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Postmenopausal women as defined by female with amenorrhea for greater than 12 months. 2. Current symptoms of GSM including at least two of the following that have a subjective assessment greater or equal to 4cm on the visual analogue scale: vaginal dryness, burning (pain), itching. 3. A Vestibular Health Score (VHS) greater or equal to 3 to less or equal to 12 4. Capable of giving informed consent. 5. Ambulatory. 6. Capable and willing to follow all study-related procedures.

Exclusion criteria

1. Are > 65 years of age 2. Use of laser therapy for treatment of GSM at any time in the past. 3. Use of any HRT (systemic or local) or raloxifene within six months of the Screening Visit through study follow up. 4. Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of Investigational product start through study follow up. 5. History of allergic reaction to any component of the study treatment. 6. Pelvic organ prolapse greater than stage II (according to the POP-Q system). 7. Any pelvic surgery within 6 months. 8. Genitourinary bleeding without a definitive diagnosis. 9. Prior vaginal or pelvic irradiation. 10. Active vaginal or urinary tract infection.

Outcome results