52 Participants Needed

Progestin Contraceptives for Birth Control Effects

WH
Overseen ByWomen's Health Research Unit Research Unit Department of OB/Gyn
Age: 18 - 65
Sex: Female
Trial Phase: Phase < 1
Sponsor: Oregon Health and Science University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The etonogestrel implant, known as Nexplanon or Implanon, is generally considered safe, but it can rarely cause moderate or severe allergic reactions. A study in France assessed its safety and found some adverse effects, but these are not common.12345

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 Edelman M.D., M.P.H. | Health ...

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

Regular menstrual cycles (25-35 day cycle length with bleeding 8 days or less)
Body Mass Index of 19-35
I can safely use birth control shots or implants.
See 1 more

Exclusion Criteria

Centers for Disease Control Medical Eligibility for Contraceptive use category 3 or 4 for contraceptive usage
I have experienced unusual bleeding from my uterus.
Chronic use of cigarettes (More than 1 cigarette per week)
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

12 months
4 visits for biopsies, regular visits for blood draws and exams

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the analysis of bleeding patterns and endometrial profiling

6 months

Treatment Details

Interventions

  • DMPA
  • Etonogestrel implant
Trial Overview 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.
Participant Groups
2Treatment groups
Active Control
Group I: DMPAActive Control1 Intervention
Group II: Etonogestrel implantActive Control1 Intervention

DMPA is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Depo-Provera for:
  • Contraception
  • Endometriosis
  • Renal carcinoma
  • Cushing's syndrome
🇪🇺
Approved in European Union as Depo-Provera for:
  • Contraception
  • Endometriosis
  • Renal carcinoma
  • Cushing's syndrome
🇨🇦
Approved in Canada as Depo-Provera for:
  • 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

Trials
1,024
Recruited
7,420,000+

Findings from Research

Nexplanon® is a long-acting contraceptive implant that is generally considered safe, but it can occasionally cause moderate to severe adverse reactions.
A specific case of delayed-type hypersensitivity reaction to Nexplanon® was reported, which resolved after the implant was removed, highlighting the importance of monitoring for potential allergic reactions.
Delayed-type hypersensitivity reaction against Nexplanon®.Serati, M., Bogani, G., Kumar, S., et al.[2014]
In a national pharmacovigilance study in France, 39 unintended pregnancies were reported among users of the Implanon contraceptive implant, primarily due to insertion technique errors (77% of cases).
The study highlights the importance of proper training for healthcare providers in the insertion of Implanon to prevent complications, as issues with insertion can lead to migration of the implant and difficulties in removal, potentially requiring invasive procedures.
[Insertion problems, removal problems, and contraception failures with Implanon].Bensouda-Grimaldi, L., Jonville-Béra, AP., Beau-Salinas, F., et al.[2014]
In a study of 385 high-risk women, those using the intrauterine device (IUD) had lower rates of discontinuation compared to those using depo-medroxyprogesterone acetate (DMPA), with 18.8% of IUD users discontinuing versus 67.0% of DMPA users.
While women using DMPA were initially found to have a higher likelihood of subsequent sexually transmitted diseases (STDs), this association diminished when accounting for other factors, suggesting that the choice of contraceptive may be influenced by sexual risk factors rather than inherent safety differences.
Long-term, reversible contraception use among high-risk women treated in a university-based gynecology clinic: comparison between IUD and depo-provera.Cropsey, KL., Matthews, C., Campbel, S., et al.[2022]

References

Delayed-type hypersensitivity reaction against Nexplanon®. [2014]
[Insertion problems, removal problems, and contraception failures with Implanon]. [2014]
Long-term, reversible contraception use among high-risk women treated in a university-based gynecology clinic: comparison between IUD and depo-provera. [2022]
[Safety profile of etonogestrel contraceptive implant (Nexplanon&#174; and Implanon&#174;) reported in France]. [2017]
Impact of etonogestrel implant use on T-cell and cytokine profiles in the female genital tract and blood. [2020]
Considerations for the use of progestin-only contraceptives. [2022]
Progestin-based contraceptive on the same day as medical abortion. [2018]
Contraception Update: Progestin-Only Implants and Injections. [2018]
Endometrial effects of etonogestrel (Implanon) contraceptive implant. [2021]