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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
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
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,137 Total Patients Enrolled
Alison Edelman, MDPrincipal InvestigatorOregon Health and Science University
2 Previous Clinical Trials
88 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced unusual bleeding from my uterus.I have a bleeding disorder.I am between 18 and 40 years old and in good health.I regularly take NSAIDs daily for at least two weeks a month.I can safely use birth control shots or implants.I have been diagnosed with polycystic ovary syndrome.I am not taking any drugs that affect the P450 enzyme system.I am using hormonal or intrauterine contraceptives, or other hormone treatments.I have a known condition affecting my uterus.I am currently using blood thinners.I use CBD, THC, or marijuana regularly (more than 3 times a week).
Research Study Groups:
This trial has the following groups:- Group 1: DMPA
- Group 2: Etonogestrel implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.