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
WEIR Science Ltd
45 participants
May 29, 2024
Interventional
Conditions
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.
Eligibility
Inclusion Criteria6
- Postmenopausal women as defined by female with amenorrhea for greater than 12 months.
- 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.
- A Vestibular Health Score (VHS) greater or equal to 3 to less or equal to 12
- Capable of giving informed consent.
- Ambulatory.
- Capable and willing to follow all study-related procedures.
Exclusion Criteria10
- Are > 65 years of age
- Use of laser therapy for treatment of GSM at any time in the past.
- Use of any HRT (systemic or local) or raloxifene within six months of the Screening Visit through study follow up.
- Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of Investigational product start through study follow up.
- History of allergic reaction to any component of the study treatment.
- Pelvic organ prolapse greater than stage II (according to the POP-Q system).
- Any pelvic surgery within 6 months.
- Genitourinary bleeding without a definitive diagnosis.
- Prior vaginal or pelvic irradiation.
- Active vaginal or urinary tract infection.
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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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12624000510549