Progestin Contraceptives for Birth Control Effects
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial requires that you stop using hormonal contraceptives and certain other medications before enrolling. Specifically, you must not have used oral hormonal contraceptives for at least one month, implantable contraceptives for at least two months, or injectable hormonal contraceptives for the past nine months. Additionally, you should not be using NSAIDs regularly or any anticoagulants.
Is the etonogestrel implant generally safe for use as a contraceptive?
How is the drug DMPA and Etonogestrel implant unique compared to other birth control options?
The DMPA injection and Etonogestrel implant are unique because they provide long-term contraception with simple options for reversal or removal. The implant is one of the most effective forms of contraception, and both methods are safe for use postpartum, during breastfeeding, and immediately after abortion. However, they may cause changes in menstrual bleeding patterns and, in the case of DMPA, potential reversible bone mineral density loss.56789
Research Team
Alison B Edelman, MD, MPH
Principal Investigator
Oregon Health and Science University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the contraceptive implant (Nexplanon) or the contraceptive injectable (Depo-Provera) for up to 12 months, with 4 endometrial biopsies, blood draws, physical exams, and pregnancy tests
Follow-up
Participants are monitored for safety and effectiveness after treatment, including the analysis of bleeding patterns and endometrial profiling
Treatment Details
Interventions
- DMPA
- Etonogestrel implant
DMPA is already approved in United States, European Union, Canada for the following indications:
- Contraception
- Endometriosis
- Renal carcinoma
- Cushing's syndrome
- Contraception
- Endometriosis
- Renal carcinoma
- Cushing's syndrome
- Contraception
- Endometriosis
- Renal carcinoma
- Cushing's syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor