TestosteroneNCT05487794
Effect of Dose Fractionation of Testosterone Cypionate on Transgender Men with Erythrocytosis
A study testing Testosterone Cypionate 100 MG/ML in people with Testosterone and Transsexualism, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
A transgender man is someone with a male identity who were born with a vulva and vagina. The acquisition of masculine characters can come from surgery or from the use of testosterone. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Testosterone, Transsexualism, Hematologic Diseases
- What is being tested?
- Testosterone Cypionate 100 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2022to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- TM aged between 18 and 40 years in threatmeant with Testosterone Cypionate 200mg/2mL with a diagnosis of erythrocytosis (Ht⩾50%).
Who cannot join
- TM with polycythemia vera or secondary to other pathologies (chronic kidney disease, severe lung disease, chronic myeloid leukemia, lymphoma, liver diseases and Cushing's syndrome);
- TM in use of hormonal contraceptives or copper IUDs;
- TM with psychiatric conditions such as severe psychotic disorders, severe personality disorders
- Patients with Ht > 54.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina de Ribeirão Preto - FMRP-USP
Ribeirão Preto, São Paulo
About this study
Official title: Effect of Dose Fractionation of Testosterone Cypionate on Hematocrit in Transgender Men with Erythrocytosis Secondary to Testosterone Use.
A transgender man is someone with a male identity who were born with a vulva and vagina. The acquisition of masculine characters can come from surgery or from the use of testosterone. Despite the benefit of using this hormone in relation to hair development, muscle mass gain and changes in voice timbre, its use can cause an increase in the hematocrit (Ht) level. When erythrocytosis occurs (Ht ≥ 50%), the currently proposed conduct is the suspension of cross-hormonization for 3 months, which has negative effects on the affirmation process. This project aims to assess whether reducing the dose of testosterone cypionate by half (100mg/15d) can mitigate the negative outcomes caused by the suspension with the benefit of reducing the hematocrit level in trans patients who developed erythrocytosis using testosterone. This is a pilot study that will compare the intervention (testosterone cypionate 100 mg, fortnightly) to the suspension of the drug, both for 3 months, with the main outcome being the hematocrit level. Hormonal and biochemical levels and the Hospital Anxiety and Depression scale (HAD) will also be evaluated in patients treated at the Gender Incongruence Outpatient Clinic of the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto.
- Conditions
- Testosterone, Transsexualism, Hematologic Diseases
- Being tested
- Testosterone Cypionate 100 MG/ML
- Medical subject headings
- Transsexualism, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Cypionate 100 MG/MLDrug
Testosterone is also responsible for increasing hematocrit by stimulating erythropoiesis (Velho et al., 2017). In cisgender men, who are hypogonadal and do not adequately produce testosterone, treatment with the use of testosterone is associated with stimulation of erythropoiesis, which can potentially increase blood viscosity, resulting in secondary erythrocytosis (Hajjar et al., 1997).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (T100) | Experimental | Not described Receives: Drug: Testosterone Cypionate 100 MG/ML |
| Group 1 (T0) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Erythrocytosis
To evaluate if the reduction of the dose of Testosterone Cypionate 200 mg to 100 mgm, biweekly, is effective to normalize the hematocrit in TM with erythrocytosis. Hemoglobin and hematocrit: will be measured by automated counting in the Biochemistry laboratory of the HCRP, using the Siemens Advia 2120i device (Siemens Healthcare GmbH®, Munich, Germany). Blood collection will be carried out in Recrututo and 3 months after intervention or control.
Measured: 3 months
Secondary outcomes (2)
Efects on lipids and glucose levels
Blood samples will be collected between seven and eight in the morning, after a minimum of twelve hours fasting. In each evaluation, 20 mL of whole blood will be collected and stored in conical plastic tubes (BD-Becton Dickinson, Plymouth, United Kingdom) with a vacuum and a separating gel barrier. It will be measured: total cholesterol (TC), HDL-cholesterol and triglycerides (TG) by enzymatic method in the Biochemistry laboratory of HCRP. The device used will be the Siemens Atellica CH 930 (Siemens Healthcare GmbH®, Munich, Germany). LDL-cholesterol will be calculated from the Friedewald formula, if there is no dosage of TG greater than 400mg/dL (Friedewald et al., 1972). Fasting blood glucose will be determined by the enzymatic method in the Biochemistry laboratory of the HCRP and the device used will be the Siemens Atellica CH 930 (Siemens Healthcare GmbH®, Munich, Germany)
Measured: 3 monsths. Blood collection will be carried out in recruitment and 3 months after intervention or control.
Anxiety and Depression Hospital Scale (HAD)
To evaluate the emotional state regarding the presence of anxiety and depression, the Brazilian version of the Hospital Anxiety and Depression Scale (HAD) will be used, which consists of 14 questions that assess some aspects of mood and behavior (Appendix 4). Scores ≥ 9 in the questions corresponding to anxiety or depression characterizes the psychic state of the woman.Zigmond \& Snaith, 1983).
Measured: The scale will be applied in recruitment and 3 months after intervention or control.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Sep 2022
- Primary completion18 Nov 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TestosteroneStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, SERGIO HENRIQUE PIRES OKANO, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487794
- Sponsor's protocol ID
- DGO-777
- Status last verified
- Mar 2025
- First submitted
- 26 Jul 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Okano SHP, Franceschini SA, Cantelli DAL, de Sa Rosa E Silva ACJ, Ferriani RA, Brito LGO, da Silva Lara LA. Effect of 100 mg of testosterone cypionate in trans men with erythrocytosis: a randomized controlled pilot study. J Sex Med. 2025 Nov 2;22(11):2149-2153. doi: 10.1093/jsxmed/qdaf263.
PubMed 41052128
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dose Fractionation of Testosterone Cypionate on Hematocrit in Transgender Men with Erythrocytosis Secondary to Testosterone Use.
- ClinicalTrials.gov ID
- NCT05487794
- Acronym / sponsor ID
- DGO-777
- Conditions
- Testosterone, Transsexualism, Hematologic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A transgender man is someone with a male identity who were born with a vulva and vagina. The acquisition of masculine characters can come from surgery or from the use of testosterone. Despite the benefit of using this hormone in relation to hair development, muscle mass gain and changes in voice timbre, its use can cause an increase in the hematocrit (Ht) level. When erythrocytosis occurs (Ht ≥ 50%), the currently proposed conduct is the suspension of cross-hormonization for 3 months, which has negative effects on the affirmation process. This project aims to assess whether reducing the dose of testosterone cypionate by half (100mg/15d) can mitigate the negative outcomes caused by the suspension with the benefit of reducing the hematocrit level in trans patients who developed erythrocytosis using testosterone. This is a pilot study that will compare the intervention (testosterone cypionate 100 mg, fortnightly) to the suspension of the drug, both for 3 months, with the main outcome being the hematocrit level. Hormonal and biochemical levels and the Hospital Anxiety and Depression scale (HAD) will also be evaluated in patients treated at the Gender Incongruence Outpatient Clinic of the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (T100) | Experimental | Drug: Testosterone Cypionate 100 MG/ML |
| Group 1 (T0) | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- TM aged between 18 and 40 years in threatmeant with Testosterone Cypionate 200mg/2mL with a diagnosis of erythrocytosis (Ht⩾50%).
Key exclusion criteria (4 listed)
- TM with polycythemia vera or secondary to other pathologies (chronic kidney disease, severe lung disease, chronic myeloid leukemia, lymphoma, liver diseases and Cushing's syndrome);
- TM in use of hormonal contraceptives or copper IUDs;
- TM with psychiatric conditions such as severe psychotic disorders, severe personality disorders
- Patients with Ht > 54.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone Cypionate 100 MG/MLTestosterone is also responsible for increasing hematocrit by stimulating erythropoiesis (Velho et al., 2017). In cisgender men, who are hypogonadal and do not adequately produce testosterone, treatment with the use of testosterone is associated with stimulation of erythropoiesis, which can potentially increase blood viscosity, resulting in secondary erythrocytosis (Hajjar et al., 1997). | Drug | Group 1 (T100) |
Primary outcome
Rate of Erythrocytosis
Time frame: 3 months
To evaluate if the reduction of the dose of Testosterone Cypionate 200 mg to 100 mgm, biweekly, is effective to normalize the hematocrit in TM with erythrocytosis. Hemoglobin and hematocrit: will be measured by automated counting in the Biochemistry laboratory of the HCRP, using the Siemens Advia 2120i device (Siemens Healthcare GmbH®, Munich, Germany). Blood collection will be carried out in Recrututo and 3 months after intervention or control.
2 secondary outcomes
Efects on lipids and glucose levels
Time frame: 3 monsths. Blood collection will be carried out in recruitment and 3 months after intervention or control.
Anxiety and Depression Hospital Scale (HAD)
Time frame: The scale will be applied in recruitment and 3 months after intervention or control.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41052128Okano SHP, Franceschini SA, Cantelli DAL, de Sa Rosa E Silva ACJ, Ferriani RA, Brito LGO, da Silva Lara LA. Effect of 100 mg of testosterone cypionate in trans men with erythrocytosis: a randomized controlled pilot study. J Sex Med. 2025 Nov 2;22(11):2149-2153. doi: 10.1093/jsxmed/qdaf263.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone Cypionate 100 MG/ML in people with Testosterone and Transsexualism, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Erythrocytosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05487794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.