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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor Research Institute
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Norethindrone; Norethindrone Acetate

Criteria

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