Transgender PersonsPhase 2NCT04534881
Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen
A Phase 2 study testing Progesterone 200 MG in people with Transgender Persons, run by St. Louis University at 1 site in United States.
Trial summary
Purpose. The purpose of this research is study the effect of progesterone therapy on testosterone levels in transwomen who are currently on gender affirming treatment with estradiol. Duration. It is expected that participation will last for 6 months (24 weeks). Study Procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Transgender Persons
- What is being tested?
- Progesterone 200 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 18 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Transwomen, currently on treatment with estradiol therapy for at least 6 months (as their standard of care gender affirming therapy)
- Has achieved serum estradiol >100 pg/ml at least once, based on clinical labs in past.
Who cannot join
- Treatment with progesterone in the last 2 months
- HIV
- Planning to go for breast enhancement or gender reassignment surgery in the next 6 months
- Known history of peanut allergy (because the study drug contains peanut oil)
- Active deep vein thrombosis, pulmonary embolism or history of these conditions
- Active arterial thromboembolic disease or history of these conditions
Show all 11Show fewer
- Active cardiovascular disorders or history of these conditions (e.g. myocardial infarction, uncontrolled hypertension >150/90 mmHg)
- Known, suspected, or history of breast cancer
- Known liver dysfunction or disease
- Known or history of gallbladder disease. This does not apply to subjects who have undergone cholecystectomy
- Known or history of hypertriglyceridemia (>400 mg/dl)
Trial locations and contacts
1 site in 1 country.
About this study
- Purpose. The purpose of this research is study the effect of progesterone therapy on testosterone levels in transwomen who are currently on gender affirming treatment with estradiol.
- Duration. It is expected that participation will last for 6 months (24 weeks).
- Study Procedures. Participants will be asked to sign an informed consent, complete a medical history, have a physical exam conducted, have a fasting blood sample taken and asked to take a study drug once daily.
- Risks. Some of the foreseeable risks or discomforts include temporary discomfort, bleeding, bruising and/or swelling in the arm from blood draw. There are no known direct risks with the use of Progesterone in Transwomen for gender affirming therapy.
- Benefits. Some of the possible benefits that may be expected include increase in fat mass, increase in breast size/fullness, decrease in masculine hair patterns.
Read the detailed description
The number of individuals with gender incongruence who present to their physician for hormone therapy has increased manifold in the last decade. Testosterone therapy in transgender men (also known as female-to-male transgender or transmen) and estrogen therapy in transgender women (also known as male-to-female transgender or transwomen) respectively is the mainstay of hormone regimen.Transwomen, who are genetically men, receive estradiol replacement with the aim of suppressing serum testosterone and achieving serum estradiol concentrations that mimic the serum concentrations of biological women. This leads to an increase in fat mass, breast growth and decreases in lean mass and masculine pattern hair. However, the results of these changes are often less than satisfactory and additional therapy is required.
Breast development is a major concern for transgender females. There is a great deal of variability among individuals, as evidenced during pubertal development.Transgender women do not achieve the same level of breast development as cisgender women do after puberty. Typically, transgender women plateau at Tanner stage III and half of the transgender women have a AAA cup size or less.Investigators plan to conduct a randomized, placebo controlled double blind study evaluating the effect of adding progesterone for 6 months to transwomen who are being treated with estradiol. The hypothesis is that progesterone will decrease serum testosterone concentrations as compared to placebo and increase breast size. Investigators will also assess its role in mood, sleep, scalp hair and androgenic hair growth.
- Conditions
- Transgender Persons
- Being tested
- Progesterone 200 MG, Placebo
- Keywords
- Testosterone, breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone 200 MGDrug
Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.
PlaceboDrug
Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.
| Study group | Role | What they receive |
|---|---|---|
| progesterone | Active comparator | subjects on active drug (progesterone) Receives: Drug: Progesterone 200 MG |
| placebo | Placebo comparator | subjects on placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Testosterone
Change from baseline till 24 weeks in serum testosterone concentrations between progesterone and placebo groups. Calculated as testosterone levels at 24 weeks minus baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start20 Oct 2020
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transgender PersonsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Singh Dhindsa, M.D., F.A.C.E, St. Louis University
- Investigators
- Sandeep Singh Dhindsa Dhindsa, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534881
- Sponsor's protocol ID
- 31144
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2020
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen
- ClinicalTrials.gov ID
- NCT04534881
- Acronym / sponsor ID
- 31144
- Conditions
- Transgender Persons
- Keywords
- Testosterone, breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Purpose. The purpose of this research is study the effect of progesterone therapy on testosterone levels in transwomen who are currently on gender affirming treatment with estradiol.
- Duration. It is expected that participation will last for 6 months (24 weeks).
- Study Procedures. Participants will be asked to sign an informed consent, complete a medical history, have a physical exam conducted, have a fasting blood sample taken and asked to take a study drug once daily.
- Risks. Some of the foreseeable risks or discomforts include temporary discomfort, bleeding, bruising and/or swelling in the arm from blood draw. There are no known direct risks with the use of Progesterone in Transwomen for gender affirming therapy.
- Benefits. Some of the possible benefits that may be expected include increase in fat mass, increase in breast size/fullness, decrease in masculine hair patterns.
Detailed description
The number of individuals with gender incongruence who present to their physician for hormone therapy has increased manifold in the last decade. Testosterone therapy in transgender men (also known as female-to-male transgender or transmen) and estrogen therapy in transgender women (also known as male-to-female transgender or transwomen) respectively is the mainstay of hormone regimen.Transwomen, who are genetically men, receive estradiol replacement with the aim of suppressing serum testosterone and achieving serum estradiol concentrations that mimic the serum concentrations of biological women. This leads to an increase in fat mass, breast growth and decreases in lean mass and masculine pattern hair. However, the results of these changes are often less than satisfactory and additional therapy is required.
Breast development is a major concern for transgender females. There is a great deal of variability among individuals, as evidenced during pubertal development.Transgender women do not achieve the same level of breast development as cisgender women do after puberty. Typically, transgender women plateau at Tanner stage III and half of the transgender women have a AAA cup size or less.Investigators plan to conduct a randomized, placebo controlled double blind study evaluating the effect of adding progesterone for 6 months to transwomen who are being treated with estradiol. The hypothesis is that progesterone will decrease serum testosterone concentrations as compared to placebo and increase breast size. Investigators will also assess its role in mood, sleep, scalp hair and androgenic hair growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progesterone | Active comparator | Drug: Progesterone 200 MGsubjects on active drug (progesterone) |
| placebo | Placebo comparator | Drug: Placebosubjects on placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Transwomen, currently on treatment with estradiol therapy for at least 6 months (as their standard of care gender affirming therapy)
- Has achieved serum estradiol >100 pg/ml at least once, based on clinical labs in past.
Key exclusion criteria (11 listed)
- Treatment with progesterone in the last 2 months
- HIV
- Planning to go for breast enhancement or gender reassignment surgery in the next 6 months
- Known history of peanut allergy (because the study drug contains peanut oil)
- Active deep vein thrombosis, pulmonary embolism or history of these conditions
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 |
|---|---|---|
| Progesterone 200 MGSubjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily. | Drug | progesterone |
| PlaceboSubjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily. | Drug | placebo |
Primary outcome
Efficacy: Testosterone
Time frame: 24 weeks
Change from baseline till 24 weeks in serum testosterone concentrations between progesterone and placebo groups. Calculated as testosterone levels at 24 weeks minus baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sandeep Singh Dhindsa Dhindsa, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Progesterone 200 MG in people with Transgender Persons, run by St. Louis University at 1 site in United States.
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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Mar 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy: Testosterone (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2024.