A study to find out if Myrecil® topical cream can help manage genitourinary symptoms in menopausal women.
- Conditions
- Genitourinary Syndrome of Menopause (GSM)Reproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12624000510549
- Lead Sponsor
- WEIR Science Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 45
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method