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Hormone Therapy
Intervention Group for Birth Control
N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at initial encounter and at follow up at 3, 6, and 12 months.
Awards & highlights
Study Summary
This trial will assess the feasibility of initiating hormonal contraception in the pediatric emergency department.
Eligible Conditions
- Birth Control
- Contraceptive Behavior
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3,6, and 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3,6, and 12 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Initiation of contraception in the ED using the electronic application
Secondary outcome measures
Contraceptive continuation
Delivery process related outcomes #1
Delivery process related outcomes #2
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 Intervention
Using an electronic application, participants answer survey questions about their sexual history, medical history, and contraceptive preferences. They will watch a video that overviews the types of hormonal contraception. Then, based on survey answers, they will be able to watch more in-depth educational videos on methods that they qualify for. Participants will only be offered methods that are considered low risk and without any contraindication based upon responses to survey screening. This may include, contraceptive implant, medroxyprogesterone acetate injection, microgestin pills, xulane patch, or intravaginal ring. Participants will then be given the opportunity to initiate contraception in the ED. All participants will be referred for follow up outpatient health services. Subjects who have medical contraindications to certain contraceptive medications will be given a standardized handout that explains why they were not eligible for the medication(s) while in the ED.
Group II: Control GroupExperimental Treatment1 Intervention
Using an electronic application, participants answer survey questions about their background, sexual history, medical history, and contraceptive preferences. They will watch a video that overviews the types of hormonal contraception with brief pros and cons of each method. Then, based on participants medical history and contraceptive preferences they will be able to watch more in-depth counseling and educational videos on contraceptive methods that they qualify for. After these videos they will be given information on where they will be able to follow up to receive these contraceptive methods if they wish to start a method. Subjects who have medical contraindications to certain hormonal contraceptive medications will be given a standardized handout that explains why they were not eligible for the medication(s), should this come up in future discussions with their providers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention Group
2020
Completed Phase 2
~7240
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,091 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,699 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the trial currently open to participants?
"This medical experiment, as detailed on clinicaltrials.gov, is not currently recruiting patients; the initial advertisement was placed in May of 2019 with a subsequent edit made at the start of September 2022. Notwithstanding this study's closure to volunteer enrolment, there are 68 other active trials that require participants right now."
Answered by AI
Does this clinical research permit individuals over the age of fifty to participate?
"As per the requirements of this study, individuals must be between 15 and 21 years old to be eligible for enrollment."
Answered by AI
Is participation in this investigation open to me?
"To be accepted into this study, a person must practice contraception and possess an age ranging between 15-21 years old. The total pool of participants is 55 people."
Answered by AI
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