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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
No Placebo-Only Group
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Initiation of contraception in the ED using the electronic application
Secondary study objectives
Contraceptive continuation
Delivery process related outcomes #1
Delivery process related outcomes #2
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,004 Previous Clinical Trials
5,185,150 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,987 Previous Clinical Trials
2,293,922 Total Patients Enrolled
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