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Progestin
Progestin for Abnormal Uterine Bleeding With Nexplanon™
Phase 4
Waitlist Available
Led By Joanna Stacey, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between ages of 14-17 with parental/guardian permission
Between the ages of 18-48
Must not have
Active liver disease
Undiagnosed headaches
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Summary
This trial looked at the effects of norethindrone acetate (NTA) in patients with Nexplanon. NTA is a medication that is used to treat menstrual disorders. The trial found that NTA was effective in treating menstrual disorders in patients with Nexplanon.
Who is the study for?
This trial is for women aged 14-48 who are not trying to get pregnant in the next two years and want a Nexplanon™ implant. Participants must be willing to track symptoms daily and attend appointments. It's not for those with liver disease, recent other birth control injections, unexplained bleeding or headaches, breast cancer history, pregnancy, severe obesity (BMI over 40), or blood clot disorders.
What is being tested?
The study tests if Norethindrone acetate (NTA), a progestin hormone, can reduce frequent or prolonged bleeding in patients using Nexplanon™ compared to a placebo. Women will either receive NTA or an inactive substance without knowing which one they're getting.
What are the potential side effects?
Possible side effects of Norethindrone acetate include headache, nausea, breast tenderness, mood changes, bloating and possibly increased risk of blood clots. The actual experience may vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Women who want to use Nexplanon™ birth control implant.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
You have unexplained headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of days of bleeding and spotting
Secondary outcome measures
Quality of life measurements
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control1 Intervention
Norethindrone acetate (NTA)
Group II: Control GroupPlacebo Group1 Intervention
Placebo to Norethindrone acetate (NTA)
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Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
201 Previous Clinical Trials
203,229 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,212 Total Patients Enrolled
Joanna Stacey, MDPrincipal InvestigatorBaylor Reserach Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You started having periods less than two years ago.You have unexplained headaches.Women who want to use Nexplanon™ birth control implant.You have a body mass index (BMI) of 40 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Control Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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