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
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 40 years at time of enrollment in good general health
- Regular menstrual cycles with cycle length between 25 and 35 days and bleeding lasting 8 days or less
- Body Mass Index (BMI) between 19 and 35
- Confirmed ovulation with screening serum progesterone greater than 3 ng/mL
- No contraindications to DMPA or hormonal implant contraceptives
You will not qualify if you...
- Use of hormonal or intrauterine contraceptives or other hormones within specified washout periods before enrollment (oral hormones at least 1 month, implants or IUDs at least 2 months, injectable contraceptives at least 9 months with return of regular cycles)
- Known uterine pathology including endometriosis, leiomyoma, adenomyosis, or active infections such as cervicitis
- Positive gonorrhea or chlamydia screening unless treated prior to enrollment
- Routine or chronic use of NSAIDs daily for 14 or more days per month
- Abnormal uterine bleeding or polycystic ovary syndrome
- Currently pregnant, planning pregnancy, less than 6 months postpartum, breastfeeding, or less than 6 weeks post-abortion
- Medical conditions that contraindicate contraceptive use as per CDC Medical Eligibility Category 3 or 4
- Use of anticoagulation or presence of bleeding disorders
- Use of P450 pathway inducing drugs
- Inability to tolerate uterine sounding at screening
- Chronic use of cannabidiol, THC, or marijuana more than 3 times per week unless washed out for at least 1 month
- Chronic cigarette smoking more than 1 cigarette per week unless ceased for at least 6 months prior to study enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive a contraceptive method (either Depo-Provera injectable or Nexplanon implant) and undergo endometrial biopsies at multiple visits.
1 enrollment visit and visits at 3, 6, 9, and 12 months for treatment with biopsies at enrollment, 3, 6, and 12 months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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