Endometrial Biopsy in Progestin Contraceptive Users
This study aims to understand how progestin contraceptives, specifically the Depo-Provera injection and the Nexplanon implant, affect your menstrual bleeding patterns during the first year of use. Researchers want to see what changes happen in the lining of your uterus (endometrium) that might lead to different bleeding. You can join if you are a woman between 18 and 40 years old, have regular periods, and meet other health criteria. The study will look at the proportion of participants who experience changes in their endometrium from the start of the study to 6 months. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 52 participants. You will choose to receive either the Depo-Provera injection or the Nexplanon implant.
- What's involved
- You will receive your chosen contraceptive for up to 12 months. You will have 4 endometrial biopsies, blood draws, physical exams, and pregnancy tests, and report daily bleeding patterns using a text or email diary.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes up to 6 months, but the study involves receiving contraception for up to 12 months.
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NCT05760144
Endometrial Biopsy in Progestin Contraceptive Users
Recruiting
EARLY_PHASE1Ages 18–40InterventionalTreatmentOregon Health and Science UniversityInvestigator-initiated
~52 participants
Updated 2025-03-20 on ClinicalTrials.gov
What's tested:DMPAEtonogestrel implant
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The proportion of participants who experienced endometrial changes
Measured over Baseline to 6 months
Conditions
Where it's being run
1 sites across 1 statesOregon1
Study leadership
- Alison Edelman, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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
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.
What this trial measures
- The proportion of participants who experienced endometrial changesBaseline to 6 months
The proportion of participants who experienced endometrial changes, as defined by any changes in gene expression