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

Study Overview
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Brief Summary
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Effects of norethindrone acetate (NTA) in patients with Nexplanon.

Detailed Description
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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™.

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

Conditions
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Birth Control, Contraception, Implant, Breakthrough Bleeding, Uterine Bleeding

Intervention / Treatment
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* Drug: Norethindrone acetate (NTA)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Hemorrhage, Norethindrone Acetate, Contraceptives