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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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Women who want to use Nexplanon™ birth control implant.

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

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)

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,175 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,923 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

Frequently Asked Questions

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

Does this trial have an age limit?

"The clinical trial's eligibility requirements state that patients must be between 14-48 years old."

Answered by AI

What disorders does Treatment Group target?

"The vasomotor system, menopause, and ovarian failure can be effectively managed through the use of Treatment Group."

Answered by AI

Is the FDA's stance on Treatment Group in line with public opinion?

"Since this is a Phase 4 trial and the treatment has been approved, our team at Power rates the safety of Treatment Group as a 3."

Answered by AI

Could I join this research project if I meet the requirements?

"Eligibility for this trial requires participants to be aged 14-48, experiencing vaginal bleeding, and willing/able to maintain a daily symptom calendar. Additionally, applicants should not desire pregnancy in the next two years and must be able to keep appointments. Participants between the ages of 14-17 may require parental/guardian permission."

Answered by AI

How many patients are participating in this clinical trial?

"That is accurate. The clinical trial was originally posted on 2/11/2021 and was most recently edited on 4/19/2021. The study is enrolling 124 patients across 1 locations."

Answered by AI

Are new participants still being sought for this clinical trial?

"From what is publicly available on clinicaltrials.gov, this trial is still recruiting patients. The initial posting was on February 11th 2021 with the most recent update being April 19th 2021."

Answered by AI

Are there any other research projects that have used Treatment Group?

"Out of the 10 global studies currently underway, 6 are in Phase 3. Of these six Phase 3 clinical trials, several are based in Orchard Park, New york; however, Treatment Group is being studied at a total of 622 facilities worldwide."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
2021. "Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04676061.
~12 spots leftby Apr 2025
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