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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04676061
• Other study ID #: 020-291
• Status: Terminated
• Phase: Phase 4
• Start date: February 11, 2021
• Est. completion date: March 10, 2023

Study information

• Verified date: March 2023
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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™.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: March 10, 2023
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Norethindrone acetate (NTA)
norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
• Placebo
Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks

Locations

Country	Name	City	State
United States	Baylor Research Institute	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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