RBR-977kxd5 Vaginal bleeding patterns and satisfaction with contraceptive implant use in trans men on testosterone therapy:clinical ...

Date of registration: 08/10/2025 ^(mm/dd/yyyy)
Last approval date : 08/10/2025 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1320-0973

• Public title:

  en

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

  pt-br

  Padrão de sangramento vaginal e satisfação com o uso de implante contraceptivo em homens trans que utilizam testosterona: estudo clínico

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 81215124.1.0000.5404
    Issuing authority: Plataforma Brasil
  • 7.155.778
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Estadual de Campinas

Sponsors

• Primary sponsor: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
• Secondary sponsor:
  • Institution: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
• Supporting source:
  • Institution: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM

Health conditions

• Health conditions:

  en

  Transgender Persons; contraception; uterine hemorrhage; testosterone

  pt-br

  Pessoas transgênero; anticoncepção; hemorragia uterina; testosterona

• General descriptors for health conditions:

  en

  N02.421.325 Health Services for Transgender Persons

  pt-br

  N02.421.325 Serviços de Saúde para Pessoas Transgênero

• Specific descriptors:

  en

  M01.270.988.750 Transgender Persons

  pt-br

  M01.270.988.750 Pessoas Transgênero

  en

  E02.875.194 Contraception

  pt-br

  E02.875.194 Anticoncepção

  en

  C12.050.351.500.852.691 Uterine Hemorrhage

  pt-br

  C12.050.351.500.852.691 Hemorragia Uterina

  en

  D04.210.500.054.079.429.824 Testosterone

  pt-br

  D04.210.500.054.079.429.824 Testosterona

Interventions

• Interventions:

  en

  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 inserted after confirming the inclusion and exclusion criteria, and participants will receive detailed instructions on the use of the method. Implanon® is a long-acting contraceptive implant (up to three years), inserted under the skin of the upper arm, which continuously releases the hormone etonogestrel, suppressing ovulation and altering uterine bleeding patterns. Although testosterone therapy in transgender men can induce amenorrhea, ovulation may still occur in some cases, making contraception necessary to prevent unplanned pregnancies in individuals who have sexual relationships with people who have a penis. Participants will be instructed to record their bleeding patterns in a menstrual calendar over a 12-month period. Follow-up will be conducted through in-person consultations every 90 days, totaling four visits during the study. These consultations will assess the occurrence of bleeding, potential adverse effects, and the participants' level of satisfaction with the contraceptive method. This is a single-arm clinical study involving 30 transgender men who will receive the insertion of a subdermal etonogestrel implant (Implanon®) in the non-dominant arm. Participants will be instructed to record their bleeding patterns in a menstrual calendar over a 12-month period. Follow-up will take place through in-person visits every three months (every 90 days), totaling four visits throughout the study. During these visits, the occurrence of bleeding episodes, possible adverse effects, and the level of satisfaction with the contraceptive method will be assessed

  pt-br

  Trata-se de um estudo clínico com braço único, envolvendo 30 homens transexuais que receberão a inserção do implante subdérmico de etonogestrel (Implanon®) no braço não dominante. Os participantes serão orientados a registrar seus padrões de sangramento em um calendário menstrual ao longo de 12 meses. O acompanhamento será realizado por meio de consultas presenciais trimestrais, a cada 90 dias, totalizando quatro visitas ao longo do estudo. Nessas ocasiões, serão avaliadas a ocorrência de sangramentos, possíveis efeitos adversos e o nível de satisfação com o método contraceptivo

• Descriptors:

  en

  E07.190 Contraceptive Devices

  pt-br

  E07.190 Dispositivos Anticoncepcionais

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 12/01/2024 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  30	F	18 Y	45 Y

• Inclusion criteria:

  en

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

  pt-br

  Homens transgênero; com idade entre 18 e 45 anos; que estejam em hormonização com testosterona; que necessitem de contracepção e/ou que desejem reduzir fluxo menstrual e/ou dismenorreia

• Exclusion criteria:

  en

  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

  pt-br

  Participantes com trombose venosa profunda; tromboembolismo ativo; doença hepática grave ativa; histórico de tumores hepáticos; sangramento vaginal anormal de causa não diagnosticada; diagnóstico atual de câncer de mama; histórico de câncer de mama; suspeita de neoplasia hormônio-dependente; alergia ao etonogestrel; alergia a qualquer componente do Implanon®; participantes que não possam comparecer ao serviço para acompanhamento durante o período de 1 ano

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Prevention	Single-group	1	N/A	Single-arm-study	4

Outcomes

• Primary outcomes:

  en

  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.

  pt-br

  Espera-se observar uma alta taxa de amenorreia ao final do período de 12 meses de seguimento e após a inserção do implante subdérmico de etonogestrel em homens transgênero em uso de terapia com testosterona

  en

  Satisfaction rates exceeding 90% are expected among transgender men using Implanon and testosterone after 12 months of follow-up

  pt-br

  Espera-se encontrar taxas de satisfação superiores a 90% em homens transgênero em uso de Implanon e testoterona após o seguimento de 12 meses

  en

  Espera-se mínimos eventos adversos em homens transgênero em terapia com testosterona em uso de implante contraceptivo com etonogestrel

  pt-br

  Minimal adverse events are expected among transgender men undergoing testosterone therapy and using the etonogestrel contraceptive implant

  en

  Continuation rates exceeding 90% are expected among transgender men using Implanon and testosterone after 12 months of follow-up

  pt-br

  Espera-se encontrar taxas de continuidade superiores a 90% em homens transgênero em uso de Implanon e testoterona após o seguimento de 12 meses

• Secondary outcomes:

  en

  There is none

  pt-br

  Não possui

Contacts

• Public contact
  • Full name: Cassia Raquel Juliato
  • • Address: Alexander Fleming 101
    • City: Campinas / Brazil
    • Zip code: 13083-881
  • Phone: +55 (19) 35319306
  • Email: cassia.raquel@gmail.com
  • Affiliation: Universidade Estadual de Campinas
   
• Scientific contact
  • Full name: Cassia Raquel Juliato
  • • Address: Alexander Fleming 101
    • City: Campinas / Brazil
    • Zip code: 13083-881
  • Phone: +55 (19) 35319306
  • Email: cassia.raquel@gmail.com
  • Affiliation: Universidade Estadual de Campinas
   
• Site contact
  • Full name: Cassia Raquel Juliato
  • • Address: Alexander Fleming 101
    • City: Campinas / Brazil
    • Zip code: 13083-881
  • Phone: +55 (19) 35319306
  • Email: cassia.raquel@gmail.com
  • Affiliation: Universidade Estadual de Campinas
   

Additional links:

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