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

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

Study Overview

• Status: Terminated
• Conditions: Contraception; Breakthrough Bleeding; Implant; Birth Control; Uterine Bleeding
• Intervention / Treatment: Drug: Placebo; Drug: Norethindrone acetate (NTA)

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joanna Stacey, MD; Phone Number: 254-724-4031; Email: Joanna.Stacey@BSWHealth.org

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76502
      • Baylor Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Placebo to Norethindrone acetate (NTA)	Drug: Placebo; Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
Active Comparator: Treatment Group; Norethindrone acetate (NTA)	Drug: Norethindrone acetate (NTA); norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days of bleeding and spotting	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measurements	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.	30 days

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Joanna Stacey, MD, Baylor Reserach Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): July 18, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Uterine Hemorrhage; Contraceptives; Norethindrone Acetate
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hemorrhage; Metrorrhagia; Uterine Hemorrhage; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Norethindrone; Norethindrone Acetate
• Other Study ID Numbers: 020-291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes