drugset / Trial / NCT05760144

Endometrial Biopsy in Progestin Contraceptive Users

NCT05760144

Phase 0 Recruiting 52 enrolled Oregon Health and Science University
Non-randomizedParallel-groupOpen-labelTreatment

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. 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).

Timeline

Start
2023-07-01
Primary completion
2026-11
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etonogestrel Unknown
Comparator medroxyprogesterone acetate Other / unclassified

Indications

No indication recorded.