Endometrial Biopsy in Progestin Contraceptive Users

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05760144
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • DMPA — DRUG
    The participant will receive the contraceptive injectable, Depo-Provera at the enrollment visit and at 3, 6, 9, and 12 months. Participants will have endometrial biopsies at the enrollment visits and at 3, 6, and 12 months.
  • Etonogestrel implant — DRUG
    The participant will receive the contraceptive implant, Nexplanon at the enrollment visits and have endometrial biopsies at the enrollment visits and at 3, 6, and 12 months.

Study Details

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).

Key Dates

Start date
Jul 1, 2023
Status verified
Aug 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DMPA
  • Active Comparator: Etonogestrel implant

Primary Outcome Measure

The proportion of participants who experienced endometrial changes [ Time Frame: Baseline to 6 months ]

Central Contacts

  • Women's Health Research Unit Research Unit Department of OB/Gyn
    503-494-3666
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSUPortlandOregon97239-

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By research site
OHSU· Portland, OR

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