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Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™

NCT04676061 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-02-02

No results posted yet for this study

Summary

Effects of norethindrone acetate (NTA) in patients with Nexplanon.

Conditions

  • Birth Control
  • Contraception
  • Implant
  • Breakthrough Bleeding
  • Uterine Bleeding

Interventions

DRUG

Norethindrone acetate (NTA)

norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks

DRUG

Placebo

Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Joanna Stacey, MD · Baylor Reserach Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2022-07-18
Completion
2023-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676061 on ClinicalTrials.gov