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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
18-40 years of age at time of enrollment in good general health
No contraindications to DMPA or hormonal implant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 40 years old and in good health.
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I can safely use birth control shots or implants.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of participants who experienced endometrial changes

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
967 Previous Clinical Trials
6,845,624 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the selection criteria for this trial allow people aged 25 and over to participate?

"This study is actively searching for participants aged between 18 and 40 years old."

Answered by AI

What are the qualifications to take part in this clinical exploration?

"This clinical trial is currently enrolling 52 individuals, who must be between 18 and 40 years old. Additionally, all participants should have reliable birth control methods in place."

Answered by AI

Are there any open slots in this research endeavor for participants?

"The information available on clinicaltrials.gov reveals that this trial has concluded recruitment. It was initially made public in March 1st, 2023 and the most recent update came February 25th, 2023. Notwithstanding, there are still 53 other trials looking for participants at present time."

Answered by AI
~23 spots leftby Nov 2024