ContraceptionEarly Phase 1NCT05760144
Endometrial Biopsy in Progestin Contraceptive Users
A Early Phase 1 study testing DMPA and Etonogestrel implant in people with Contraception, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use. 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
- Contraception
- What is being tested?
- DMPA and Etonogestrel implant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 9 Sep 2026
- Phase
- Early Phase 1
- 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
- 18-4 0 years of age at time of enrollment in good general health
- Regular menstrual cycles (25-35 day cycle length with bleeding 8 days or less)
- Body Mass Index of 19-35
- Confirmed ovulation with a screening serum progesterone of greater than 3ng/mL
- No contraindications to DMPA or hormonal implant
Who cannot join
- Hormonal or intrauterine contraceptives or other hormone use prior to start of study enrollment [No oral hormonal contraceptives or other hormones for at least one month, no implantable contraceptives or hormonal or non-hormonal intrauterine device for at least two months (2 cycles), no injectable hormonal contraceptives or other hormones in past 9 months from the most recent injection and resumption of regular menstrual cycles]. Of note, patients could have used an implant or DMPA in past but must have the same washout time periods as noted before.
- Any known uterine pathology (endometriosis, leiomyoma or adenomyosis; bacterial, fungal or viral infection, active cervicitis). For bacterial infection such as gonorrhea (GC) /chlamydia (CT) enrollment should be delayed until treatment complete. For vaginitis (bacterial vaginosis or yeast) enrollment can occur at time of diagnosis if patient prefers. Test of cure is not required to proceed with enrollment.
- Positive gonorrhea/chlamydia screening performed at screening visit, unless treated as noted above.
- Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or more 14 or more days per month)
- Abnormal uterine bleeding
- Polycystic ovary syndrome
Show all 15Show fewer
- Currently pregnant or planning pregnancy during the study
- Less than 6 month postpartum or breastfeeding, post abortion 6 weeks, not breast/chest feeding (cessation 4-6 weeks from enrollment)
- Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4 for contraceptive usage (Current or prior medical history of thrombosis or thromboembolic disorders, Liver tumors or active liver disease, Current or prior medical history of breast cancer, Hypertension defined as 160/100 or greater, Ischemic heart disease or multiple risk factors for atherosclerotic cardiovascular disease, Rheumatoid arthritis on immunosuppressive therapy, History of stroke, Systemic lupus erythematosus, Unexplained vaginal bleeding, Diabetes of greater than 20 years duration or with evidence with end-organ disease)
- Anticoagulation use
- Bleeding dyscrasia
- Use of P450 pathway inducing drug(s)
- Inability to tolerate uterine sounding (at screening visit)
- Chronic use of Cannabidiol, THC, or marijuana (More than 3 times per week). Of note, patients could have used Cannabidiol, THC, or marijuana chronically in past, but must have a washout time period of no use for at least one month prior to the study.
- Chronic use of cigarettes (More than 1 cigarette per week). Of note, patients could have used cigarettes chronically in past, but must have a washout time period of no use for at least six months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use. Participants will choose to receive the contraceptive implant (Etonogestrel implant also called Nexplanon) or the contraceptive injectable (Depo-medroxyprogesterone acetate (DMPA) also called Depo-Provera) for up to 12 months. They will be asked to have 4 endometrial biopsies over the course of the study, as well as blood draws, physical exams, and pregnancy tests. Participants will also use a daily text message or email diary to report bleeding patterns. This study's plan is to comprehensively phenotype bleeding patterns and profile the entire endometrium using single-cell RNA seq data (sCRNAseq).
- Conditions
- Contraception
- Being tested
- DMPA, Etonogestrel implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMPADrug
Also called Depo-Provera
The participant will receive the contraceptive injectable, Depo-Provera at the enrollment visit and at 3, 6, 9, and 12 months. Participants will have endometrial biopsies at the enrollment visits and at 3, 6, and 12 months.
Etonogestrel implantDrug
Also called Nexplanon
The participant will receive the contraceptive implant, Nexplanon at the enrollment visits and have endometrial biopsies at the enrollment visits and at 3, 6, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| DMPA | Active comparator | Not described Receives: Drug: DMPA |
| Etonogestrel implant | Active comparator | Not described Receives: Drug: Etonogestrel implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants who experienced endometrial changes
The proportion of participants who experienced endometrial changes, as defined by any changes in gene expression
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Jul 2023
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alison Edelman, Oregon Health and Science University
- Investigators
- Alison Edelman, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760144
- Sponsor's protocol ID
- STUDY00025084
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Biopsy in Progestin Contraceptive Users
- ClinicalTrials.gov ID
- NCT05760144
- Acronym / sponsor ID
- STUDY00025084
- Conditions
- Contraception
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 8 Mar 2023 (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.
The purpose of the study is to learn more about menstrual changes in progestin contraception users. The investigators are hoping to find out what changes in the endometrium lead to different bleeding patterns during the first year of progestin contraception use. Participants will choose to receive the contraceptive implant (Etonogestrel implant also called Nexplanon) or the contraceptive injectable (Depo-medroxyprogesterone acetate (DMPA) also called Depo-Provera) for up to 12 months. They will be asked to have 4 endometrial biopsies over the course of the study, as well as blood draws, physical exams, and pregnancy tests. Participants will also use a daily text message or email diary to report bleeding patterns. This study's plan is to comprehensively phenotype bleeding patterns and profile the entire endometrium using single-cell RNA seq data (sCRNAseq).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMPA | Active comparator | Drug: DMPA |
| Etonogestrel implant | Active comparator | Drug: Etonogestrel implant |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-4 0 years of age at time of enrollment in good general health
- Regular menstrual cycles (25-35 day cycle length with bleeding 8 days or less)
- Body Mass Index of 19-35
- Confirmed ovulation with a screening serum progesterone of greater than 3ng/mL
- No contraindications to DMPA or hormonal implant
Key exclusion criteria (15 listed)
- Hormonal or intrauterine contraceptives or other hormone use prior to start of study enrollment [No oral hormonal contraceptives or other hormones for at least one month, no implantable contraceptives or hormonal or non-hormonal intrauterine device for at least two months (2 cycles), no injectable hormonal contraceptives or other hormones in past 9 months from the most recent injection and resumption of regular menstrual cycles]. Of note, patients could have used an implant or DMPA in past but must have the same washout time periods as noted before.
- Any known uterine pathology (endometriosis, leiomyoma or adenomyosis; bacterial, fungal or viral infection, active cervicitis). For bacterial infection such as gonorrhea (GC) /chlamydia (CT) enrollment should be delayed until treatment complete. For vaginitis (bacterial vaginosis or yeast) enrollment can occur at time of diagnosis if patient prefers. Test of cure is not required to proceed with enrollment.
- Positive gonorrhea/chlamydia screening performed at screening visit, unless treated as noted above.
- Routine or chronic use of non-steroidal anti-inflammatory drugs (NSAIDs once daily or more 14 or more days per month)
- Abnormal uterine bleeding
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 |
|---|---|---|
| DMPAAlso: Depo-ProveraThe participant will receive the contraceptive injectable, Depo-Provera at the enrollment visit and at 3, 6, 9, and 12 months. Participants will have endometrial biopsies at the enrollment visits and at 3, 6, and 12 months. | Drug | DMPA |
| Etonogestrel implantAlso: NexplanonThe participant will receive the contraceptive implant, Nexplanon at the enrollment visits and have endometrial biopsies at the enrollment visits and at 3, 6, and 12 months. | Drug | Etonogestrel implant |
Primary outcome
The proportion of participants who experienced endometrial changes
Time frame: Baseline to 6 months
The proportion of participants who experienced endometrial changes, as defined by any changes in gene expression
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 14 Oct 2026.
Related trials for Contraception
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Not yet recruitingPhase 3
Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)
Contraception
Recruiting
Prospective Multi-Center Trial for FemBloc Permanent Birth Control
Contraception
RecruitingObservational study
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Primary Immune Deficiency Diseases
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.
Alison Edelman, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DMPA and Etonogestrel implant in people with Contraception, run by Oregon Health and Science 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 5 inclusion and 15 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 14 Oct 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of participants who experienced endometrial changes (time frame: Baseline to 6 months). 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 14 Oct 2026.