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Endometrial Biopsy in Progestin Contraceptive Users

StatusCompleted
PhaseEarly Phase 1
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 59 participants (planned 52)
    • Primary completion date changed from estimate of Nov 2026 to Sep 9, 2026
    • Eligibility criteria expanded, about 20 words
    • Site details revised
  2. Primary completion date: Nov 2024 to Nov 2026
    • Study completion date: Nov 2025 to Nov 2026
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Start date changed from estimate of Apr 2023 to Jul 1, 2023v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2023 to Apr 2023
    • Site details revised
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05760144
Lead Sponsor Oregon Health and Science University
Conditions
(from sponsor)		 Contraception
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov