Understanding menstrual changes in users of progestin contraception
Endometrial Biopsy in Progestin Contraceptive Users
This study is testing how different progestin contraceptives affect menstrual changes and bleeding patterns in people over a year.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05760144 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the menstrual changes experienced by individuals using progestin-based contraceptives. Participants will choose between two methods: the Etonogestrel implant or the Depo-Provera injection, and will undergo four endometrial biopsies over a year. The study will collect data on bleeding patterns through daily diaries and will analyze the endometrial tissue using advanced single-cell RNA sequencing techniques. The goal is to identify the endometrial changes that correlate with different bleeding patterns during the first year of contraceptive use.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-40 in good health with regular menstrual cycles who meet specific hormonal and health criteria.
Not a fit: Patients with known uterine pathologies or those currently using hormonal contraceptives may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and management of menstrual irregularities associated with progestin contraceptives.
How similar studies have performed: While there have been studies on hormonal contraceptives, this specific approach using single-cell RNA sequencing to analyze endometrial changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Portland, Oregon
- Ohsu — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Alison Edelman, MD — Oregon Health and Science University
- Study coordinator: Women's Health Research Unit Research Unit Department of OB/Gyn
- Email: whru@ohsu.edu
- Phone: 503-494-3666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.