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

Phase 4

Terminated

• Conditions: Breakthrough Bleeding; Uterine Bleeding; Implant; Birth Control; Contraception
• Interventions: Drug: Placebo; Drug: Norethindrone acetate (NTA)

• Registration Number: NCT04676061
• Lead Sponsor: Baylor Research Institute

Brief 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™.

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Study Start: 2021-02-11
• Primary Completion: 2022-07-18
• Status Verified: 2023-03
• Study Completion: 2023-03-10
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 51

Inclusion Criteria

• Between the ages of 18-48
• Between ages of 14-17 with parental/guardian permission
• Women desiring placement of Nexplanon™
• Willing to keep a daily symptom calendar
• Keep appointments
• Women not desiring to become pregnant in the next 2 years

Exclusion Criteria

• Known or suspected Pregnancy
• Less than 8weeks postpartum
• Menarche less than two years ago
• Current or past history of thrombosis or thromboembolic disorders
• Hepatic tumors (benign or malignant)
• Active liver disease
• Undiagnosed abnormal genital bleeding
• Undiagnosed headaches
• Known or suspected carcinoma of the breast or personal history of breast cancer
• Hypersensitivity to any of the components in Nexplanon™
• BMI greater than 40
• Depomedroxyprogesterone acetate injection in the previous 12 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Placebo to Norethindrone acetate (NTA)
Treatment Group	Norethindrone acetate (NTA)	Norethindrone acetate (NTA)

Primary Outcome Measures

Name	Time	Method
Number of days of bleeding and spotting	30 days	To evaluate days of bleeding and spotting within 90-day intervals by quantifying a self-perception of amount of bleeding on a scale of 0 to 4 and associated symptoms on a scale of 0 to 10 using the Daily Dairy of Symptoms

Secondary Outcome Measures

Name	Time	Method
Quality of life measurements	30 days	To evaluate quality of life by comparing the treatment and placebo groups' associated symptoms on a scale of 0 to 10 using the Daily Diary of Symptoms.

Trial Locations

Locations (1)

Baylor Research Institute; 🇺🇸 Temple, Texas, United States