Actively Recruiting
Endometrial Biopsy in Progestin Contraceptive Users
Led by Oregon Health and Science University · Updated on 2025-03-20
52
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Endometrial Biopsy in Progestin Contraceptive Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 to 40 years old, in good general health at enrollment
- Regular menstrual cycles (25-35 days) with bleeding lasting 8 days or less
- Body Mass Index between 19 and 35
- Confirmed ovulation indicated by serum progesterone greater than 3 ng/mL
- No medical reasons preventing use of Depo-Provera or contraceptive implant
You will not qualify if you...
- Use of hormonal or intrauterine contraceptives or hormones within specified washout periods before enrollment
- Known uterine diseases such as endometriosis, fibroids, adenomyosis, or infections
- Positive test for gonorrhea or chlamydia at screening unless treated
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) 14 or more days per month
- Abnormal uterine bleeding or polycystic ovary syndrome
- Currently pregnant or planning pregnancy during the study
- Less than 6 months postpartum, breastfeeding, or recent abortion within specified time frames
- Medical conditions or histories that contraindicate contraceptive use according to CDC guidelines
- Use of blood thinners or bleeding disorders
- Use of drugs affecting hormone metabolism (P450 pathway inducers)
- Inability to tolerate uterine sounding at screening
- Frequent use of cannabis products or cigarettes without required washout periods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
OHSU
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
W
Women's Health Research Unit Research Unit Department of OB/Gyn
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here