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Progestin Contraceptive

Progestin Contraceptives for Birth Control Effects

Phase < 1
Recruiting
Led By Alison Edelman, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how progestin contraception affects menstrual patterns and the endometrium. Participants will receive contraceptive implant or injectable for 12 months & be asked to report bleeding patterns. 4 endometrial biopsies & blood draws, physical exams & pregnancy tests will be done. sCRNAseq will be used to profile the endometrium.

Who is the study for?
This trial is for women aged 18-40 with regular menstrual cycles, a BMI of 19-35, and no contraindications to DMPA or hormonal implants. They shouldn't be pregnant, breastfeeding, or planning pregnancy during the study; have used certain contraceptives recently; have uterine pathology; fall under CDC's category 3/4 for contraceptive use; smoke heavily; or take specific medications regularly.
What is being tested?
The study examines how progestin contraception (Nexplanon implant or Depo-Provera injection) affects menstrual changes by analyzing endometrial biopsies and blood samples over a year. Participants will also track their bleeding patterns daily via text or email.
What are the potential side effects?
Potential side effects from Nexplanon implant or Depo-Provera injection include irregular bleeding patterns, discomfort at the site of insertion/injection, weight changes, headaches, mood swings, and possible decrease in bone density.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of participants who experienced endometrial changes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: DMPAActive Control1 Intervention
Group II: Etonogestrel implantActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,867 Total Patients Enrolled
Alison Edelman, MDPrincipal InvestigatorOregon Health and Science University
2 Previous Clinical Trials
88 Total Patients Enrolled

Media Library

DMPA (Progestin Contraceptive) Clinical Trial Eligibility Overview. Trial Name: NCT05760144 — Phase < 1
Birth Control Research Study Groups: DMPA, Etonogestrel implant
Birth Control Clinical Trial 2023: DMPA Highlights & Side Effects. Trial Name: NCT05760144 — Phase < 1
DMPA (Progestin Contraceptive) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05760144 — Phase < 1
~22 spots leftby Nov 2025
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