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

Phase 4TerminatedNCT04676061

Baylor Research Institute51 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Birth Control Contraception Implant Breakthrough Bleeding Uterine Bleeding

Interventions

Norethindrone acetate (NTA)DRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 48 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Baylor Research Institute

Temple, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 30 days

Data from ClinicalTrials.gov

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