The characteristics of vaginal microbiome comparing pre and post testosterone treatment in transgender men before sex reassignment surgery.

• Conditions: 20 to 40-year-old Transgender men requiring Testosterone treatment; Transmen; Vaginal microbiome; Vaginal microbiota; Vaginal symptoms; Transgender men; Testosterone

• Registration Number: TCTR20210202007
• Lead Sponsor: Ratchadapisek Sompoch grant

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Study Completion: 2023-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

1. 20 to 40-year-old Transgender men who come to follow up at Transgender clinic of KCMH
2. Transmen who have not received testosterone
3. Transmen who have not undergone sex reassignment surgery or ovarian surgery
4. Transmen who agree to participate in research by signing
5. Transmen who able to communicate in Thai or English

Exclusion Criteria

1. History of GSM treatment within the past 3 months includes Vaginal Lubricants, Vaginal moisturizing, systemic or local sex hormones, similar products such as Tibolone,
Vaginal Laser Treatment
2. History of vaginal douche within the last 3 months
3. History of receiving vaginal medication within the last 3 months.
4. History of receiving Spermicide within the last 3 months
5. History of vaginal surgery within the last 3 months.
6. History of exposing to radiation in the pelvic area
7. History of hormonal disorders and still undergoing treatment or receiving medications that affect hormonal function.
8. Symptoms of vaginal discharge, clinical signs of vaginal infection, bleeding or urinary tract infection within the past 1 month
9. History of serious underlying disease or medical diseases, such as chronic kidney disease, Chronic liver disease or all kinds of cancers.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal microbiome at 12 weeks after Testosterone treatment Gene analysis 16S rDNA sequencing

Secondary Outcome Measures

Name	Time	Method
Vaginal atrophy signs and symptoms at 12 weeks after Testosterone treatment The most bothersome symptom score, Vaginal atrophy score, Vaginal pH, Vaginal maturation value, The number of lactobacilli, Normal flora score