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Early Phase 1
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID05760144

Study of Menstrual Changes and Endometrial Biopsies in Women Using Progestin Contraceptives Comparing Nexplanon Implant and Depo-Provera Injectable Over 12 Months

Led by Oregon Health and Science University · Updated on 2025-03-20

52

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying menstrual changes in women using progestin contraception to understand how changes in the lining of the uterus endometrium affect bleeding patterns during the first year of use. This early phase 1 trial focuses on two types of progestin contraception the contraceptive implant called Etonogestrel implant Nexplanon and the injectable Depo-medroxyprogesterone acetate DMPA or Depo-Provera. Participants will receive either the contraceptive implant or the injectable. Those receiving DMPA will get injections at enrollment and at 3, 6, 9, and 12 months, while those with the implant will have it placed at enrollment. Both groups will undergo endometrial biopsies at enrollment and at 3, 6, and 12 months to study changes in the uterus lining. During the study, participants will have blood draws, physical exams, pregnancy tests, and will report daily bleeding patterns through text or email diaries. The study will use advanced RNA sequencing to analyze the uterine lining and will measure the proportion of participants experiencing endometrial changes from baseline to 6 months. Participation lasts up to 12 months with multiple visits and monitoring throughout.

CONDITIONS

Brief Title

Endometrial Biopsy in Progestin Contraceptive Users

Research Team

W

Women's Health Research Unit Research Unit Department of OB/Gyn

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