GenderNCT06230770
Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating GATT
An observational study of Gender and Contraception, run by University of California, San Diego at 1 site in United States.
Trial summary
Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender, Contraception
- What is being tested?
- Bleeding data
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We will enroll 160 participants who are English-speaking, at least 18 years old, currently have a uterus and ovaries, desire to initiate GATT, and potentially desire to initiate a progestin (within 14 days of GATT initiation). To ensure generalizability of results, participants with baseline irregular bleeding will not be excluded. Participants who have recently initiated a progestin may be eligible for inclusion. Participants who have had gender-affirming surgery to remove their uterus and/or ovaries will not be eligible for inclusion. We will recruit participants from clinics in San Diego that prescribe GATT, including the UCSD OBGYN clinic, two UCSD Gender Health program affiliated clinics, and UCSD Student Health Services.
Who may be able to join
- English-speaking currently have a uterus and ovaries
- desire to initiate GATT
- potential desire to initiate a progestin (within 14 days of GATT initiation)
Who cannot join
- previous gender-affirming surgery to remove their uterus and/or ovaries
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92037
About this study
Official title: The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation
Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method.
- Conditions
- Gender, Contraception
- Being tested
- Bleeding data
- Keywords
- progestin, testosterone, gender-affirming, bleeding
- Medical subject headings
- Coitus, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleeding dataBehavioural
Participants will report their daily bleeding patterns
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean days bleeding or spotting
mean number of days of bleeding or spotting during the 30 days after GATT initiation
Measured: Start of GATT to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Feb 2024
- Primary completion10 Jun 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Averbach, MD MAS, University of California, San Diego
- Investigators
- Kelsey Loeliger, MD. PhD, Study director, UC San DiegoSarah Averbach, MD, MSc, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230770
- Sponsor's protocol ID
- 809057
- Status last verified
- Jun 2025
- First submitted
- 19 Jan 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Progestin-only Contraception on Bleeding Patterns in Individuals Initiating Testosterone Therapy for Gender Affirmation
- ClinicalTrials.gov ID
- NCT06230770
- Acronym / sponsor ID
- 809057
- Conditions
- Gender, Contraception
- Keywords
- progestin, testosterone, gender-affirming, bleeding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2024 (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.
Gender diverse individuals who use gender-affirming testosterone therapy (GATT) to reduce gender dysphoria may also use progestins for contraception and to manage or suppress uterine bleeding. Research is limited, however, regarding expected bleeding patterns for individuals who choose to initiate GATT concurrently with a progestin. Clinicians who prescribe GATT do not have sufficient data to adequately counsel patients on side effects of concurrent progestin use and therefore extrapolate from studies conducted in cisgender women. This study is a prospective cohort study evaluating bleeding patterns and satisfaction among patients initiating GATT with or without concurrent initiation of a progestin contraceptive. The results from this study will enable clinicians to more accurately counsel patients using GATT on how the use of a progestin might affect their bleeding and whether this differs by progestin method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We will enroll 160 participants who are English-speaking, at least 18 years old, currently have a uterus and ovaries, desire to initiate GATT, and potentially desire to initiate a progestin (within 14 days of GATT initiation). To ensure generalizability of results, participants with baseline irregular bleeding will not be excluded. Participants who have recently initiated a progestin may be eligible for inclusion. Participants who have had gender-affirming surgery to remove their uterus and/or ovaries will not be eligible for inclusion. We will recruit participants from clinics in San Diego that prescribe GATT, including the UCSD OBGYN clinic, two UCSD Gender Health program affiliated clinics, and UCSD Student Health Services.
Key inclusion criteria (3 listed)
- English-speaking currently have a uterus and ovaries
- desire to initiate GATT
- potential desire to initiate a progestin (within 14 days of GATT initiation)
Key exclusion criteria (1 listed)
- previous gender-affirming surgery to remove their uterus and/or ovaries
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 |
|---|---|---|
| Bleeding dataParticipants will report their daily bleeding patterns | Behavioural | – |
Primary outcome
Mean days bleeding or spotting
Time frame: Start of GATT to 30 days
mean number of days of bleeding or spotting during the 30 days after GATT initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- 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.
Kelsey Loeliger, MD. PhD study director
UC San Diego
Sarah Averbach, MD, MSc principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender and Contraception, run by University of California, San Diego 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 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 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean days bleeding or spotting (time frame: Start of GATT to 30 days). 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 9 Jul 2025.