Comparative study of vitamin D vaginal suppository and oral administration on vaginal symptoms in women with breast cancer
- Conditions
- Vitamin D treatment for genitourinary syndrome of menopause (GSM) symptoms in postmenopausal women with breast cancerUrological and Genital Diseases
- Registration Number
- ISRCTN33082642
- Lead Sponsor
- Khon Kaen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 76
1. Breast cancer
2. Treated with aromatase inhibitors or GnRH agonists for longer than 12 weeks
3. Aged 20-80 years old
4. Menopause (defined as no menstruation in the past 12 months)
5. Presented with most bothersome vaginal symptoms (defined as the visual analog scores >= 4 scores by interview)
6. Serum total vitamin D < 30 ng/ml
7. Willing to participate with signed informed consent
1. History of hormonal use or vitamin D supplement within 12 weeks
2. Recurrent breast cancer
3. History of procedure or vaginal product use within 12 weeks
4. History of vulvovaginal infection within 12 weeks
5. History of abnormal PAP smear
6. History of vitamin D allergy
7. History of intestinal disease
8. Active hepatic disease
9. Impair renal function (GFR < 60 ml/min/1.73m2)
10. Refused to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bothersome vaginal symptoms of GSM measured using a visual analog scale (VAS) at baseline, 6, and 12 weeks
- Secondary Outcome Measures
Name Time Method The following secondary outcome measures are assessed at baseline and 12 weeks:<br>1. Vaginal health index (VHI) measured using a vaginal health index (VHI) score<br>2. Vaginal Maturation Index measured using a vaginal maturation index (VMI) score<br>3. Vaginal pH measured using pH paper<br>4. Serum vitamin D level measured using blood specimen analyzed by electrochemiluminescence binding assay<br>