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Progestin

Progestin for Abnormal Uterine Bleeding With Nexplanon™

Temple, TX
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
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of days of bleeding and spotting
Secondary study objectives
Quality of life measurements

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.

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)

Find a Location

Closest Location:Baylor Research Institute· Temple, TX

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
207 Previous Clinical Trials
203,386 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,077 Previous Clinical Trials
5,219,065 Total Patients Enrolled
Joanna Stacey, MDPrincipal InvestigatorBaylor Reserach Institute

Media Library

Norethindrone Acetate (NTA) (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT04676061 — Phase 4
Birth Control Research Study Groups: Treatment Group, Control Group
Birth Control Clinical Trial 2023: Norethindrone Acetate (NTA) Highlights & Side Effects. Trial Name: NCT04676061 — Phase 4
Norethindrone Acetate (NTA) (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04676061 — Phase 4
~10 spots leftby Mar 2026
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