Vaginal bleeding patterns and satisfaction with contraceptive implant use in trans men on testosterone therapy:clinical study

Vaginal Bleeding Pattern and Satisfaction with the Use of the Etonogestrel Implant in transgender Men on Testosterone therapy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-977kxd5

Enrollment

Unknown

Registered

2025-08-10

Start date

2024-12-01

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Transgender Persons

Interventions

The intervention consists of the insertion of a subdermal etonogestrel (ENG) implant, commercially known as Implanon®, in 30 transgender men undergoing testosterone therapy. The implant will be insert

E07.190

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Transgender men; aged between 18 and 45 years; undergoing testosterone therapy; requiring contraception and/or wishing to reduce menstrual flow and/or dysmenorrhea

Exclusion criteria

Exclusion criteria: Participants with deep vein thrombosis; active thromboembolism; active severe liver disease; history of hepatic tumors; unexplained abnormal vaginal bleeding; current diagnosis of breast cancer; past diagnosis of breast cancer; suspected hormone-dependent neoplasia; known allergy to etonogestrel allergy to any component of Implanon®; participants who are unable to attend follow-up visits for a period of 1 year

Design outcomes

Primary

Measure	Time frame
A high rate of amenorrhea is expected at the end of the 12-month follow-up period after the insertion of the subdermal etonogestrel implant in transgender men undergoing testosterone therapy.;Satisfaction rates exceeding 90% are expected among transgender men using Implanon and testosterone after 12 months of follow-up;Espera-se mínimos eventos adversos em homens transgênero em terapia com testosterona em uso de implante contraceptivo com etonogestrel ;Continuation rates exceeding 90% are expected among transgender men using Implanon and testosterone after 12 months of follow-up	—

Measure

Time frame

A high rate of amenorrhea is expected at the end of the 12-month follow-up period after the insertion of the subdermal etonogestrel implant in transgender men undergoing testosterone therapy.;Satisfaction rates exceeding 90% are expected among transgender men using Implanon and testosterone after 12 months of follow-up;Espera-se mínimos eventos adversos em homens transgênero em terapia com testosterona em uso de implante contraceptivo com etonogestrel ;Continuation rates exceeding 90% are expected among transgender men using Implanon and testosterone after 12 months of follow-up

—

Secondary

Measure	Time frame
There is none	—

Countries

Brazil

Contacts

Public ContactCassia Juliato

Universidade Estadual de Campinas

cassia.raquel@gmail.com+55 (19) 35319306

Outcome results

None listed

Source: REBEC (via WHO ICTRP)