The improvement of neovaginal symptoms and microbiota in transgender women who received E3 and lactobacilli via vaginal suppository

Phase 4

• Conditions: neovaginal symptoms (discharge) in transgender women; Microbiota, Microbiome, Neovagina, Sexual reassignment surgery, Transgender woman, Transwoman, Transfeminine, Lactobacillus, Penile inversion

• Registration Number: TCTR20240515007
• Lead Sponsor: Ratchadapiseksompotch fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

1. Transgender woman who undergone vaginoplasty more than 6 months (inverted penile skin flap technique)
2. Have vaginal symptom (discharge)
3. Can communicate in Thai

Exclusion Criteria

1. Infected abnormal discharge (fungi, parasite)
2. Vaginal douche within 3 days
3. Sexual intercourse via neovaginal route within 3 days
4. Antibiotic used within 4 weeks
5. Medical drug use via neovagina within 4 weeks
6. Active complication from surgery or last treatment within 6 months
7. Unable to follow up
8. Medical condition (DM, autoimmune disease, HIV, cancer)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neovaginal discharge at the day after end of the intervention visual analog scale

Secondary Outcome Measures

Name	Time	Method
eovaginal microbiome species at the day after end of the intervention 16S rDNA Next Generation Sequencing