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The influence of testosterone administration on pelvic organ changes and sexual functioning in transmasculine and gender-diverse persons: a quantitative assessment using magnetic resonance imaging

The influence of testosterone administration on pelvic organ changes and sexual functioning in transmasculine and gender-diverse persons: a quantitative assessment using magnetic resonance imaging - IMPAC-T (Imaging Morphologic Pelvic Anatomy Changes due to Testosterone)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57385
Enrollment
12
Registered
2025-03-14
Start date
2025-08-07
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

sexual (dys)function sexual (dys)functioning

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: • Transmasculine or gender-diverse persons assigned female at birth diagnosed with gender dysphoria; • Age >18 years; • Scheduled to begin testosterone treatment within one to three months; • Ability to provide written consent.

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: • Medical or mental conditions (acute or chronic) affecting genital response; • History of hysterectomy, vaginal surgery, gynaecologic disease or malignancy, pelvic inflammatory disease, vaginal infection, or anatomical variations such as intersex conditions; • Current pregnancy or recent delivery within the last 12 months; • Self-reported genital dysphoria to the extent that participation is undesirable. • Contraindications to MRI, including pacemakers, metal implants, or severe claustrophobia.

Design outcomes

Primary

MeasureTime frame
The primary endpoints are clitoral and pelvic floor musculature volume (expressed in mm3) and the percentage changes in volume (expressed in %) between measurements prior to starting testosterone administration and after nine months of treatment in transmasculine and gender-diverse persons.

Secondary

MeasureTime frame
Secondary endpoints are pelvic floor musculature volume and clitoral volume (expressed in mm3) and percentage changes in clitoral volume (expressed in %) during audiovisual sexual stimulation, self-reported feelings of sexual arousal during audiovisual sexual stimulation, and sexual function assessed by an adapted sexual function questionnaire.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)