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Comparison of vaginal moisturizers with ultra-low dose estriol&Lactobacillus acidophilus vaginal tablets in pelvic organ prolapse women who were treated with vaginal pessary: a randomized controlled trial

Comparison of vaginal moisturizers with ultra-low dose estriol&Lactobacillus acidophilus vaginal tablets in pelvic organ prolapse women who were treated with vaginal pessary: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160621001
Enrollment
60
Registered
2016-06-21
Start date
2016-06-27
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

pelvic organ prolapse vaginal estrogen vaginal moisturizer pessary pelvic organ prolapse vaginal estrogen vaginal moisturizer pessary

Interventions

Regelle® is a fast acting hormone&#45
free vaginal moisturiser designed to provide instant and long&#45
lasting relief from the symptoms of menopausal and post&#45
menopausal vaginal dryness. Regelle® can be used in conjunction with hormone replacement therapy (HRT) for the symptomatic relief of vaginal dryness but is not intended for use as a substitute for HR
Regelle® has a pH which is compatible with a healthy vaginal environment. Multiple applications of the gel results in a change of pH towards the normal physiological range found in pre&#45
menopausal women. Each application of Regelle® provides a moisturising effect for up to 3 days,The ingredients of Gynoflor® consists of viable Lactobacillus acidophilus KS400 and a low dose of estri
Experimental Drug,Active Comparator Drug
vaginal moisturizer (Regelle),ultra&#45
low dose estriol&Lactobacillus acidophilus vaginal tablet

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol Universityv
Lead Sponsor
Faculty of Medicine Ramathibodi Hospital&#44
Collaborator
Mahidol University
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: - Patient is able to take care, insert, and remove pessary by herself - Did not use vaginal estrogen or vaginal mositurizers within 3 months - Informed consent

Exclusion criteria

Exclusion criteria: - Using HRT - Had contraindication for estrogen - Undiagnosed abnormal vaginal bleeding - Taking corticosteroid, or immunosuppresants

Design outcomes

Primary

MeasureTime frame
satisfaction of ultra-low dose estriol&Lactobacillus vaginal tablets and vaginal moisturizer in pess before, at 4 and 6 months after intervention likert scale—

Secondary

MeasureTime frame
subjective outcome before, at 4 and 6 months after intervention symptoms,objective outcome before, at 4 and 6 months after intervention pelvic exam, vaginal discharge, bacterial vaginosis,adverse events before, at 4 and 6 months after intervention death, cardiovascular events, cerebrovascular event, breast cancer—

Countries

Thailand

Contacts

Public ContactOrawee Chinthakanan

Ramathibodi Hospital

orawee.chi@mahidol.ac.th+66819522215

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026