NCT04676061

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

Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: Female
• Age: 14 Years – 48 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

The purpose of this study is to find out what effects norethindrone acetate (NTA) has on the duration and recurrence of frequent and/or prolonged bleeding associated with Nexplanon™.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-11
• Primary completion: 2022-07-18
• Completion: 2023-03-10
• First posted: 2020-12-19
• Last updated: 2024-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study