Status:
TERMINATED
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Birth Control
Contraception
Eligibility:
FEMALE
14-48 years
Phase:
PHASE4
Brief Summary
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
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™.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04676061
Start Date
February 11 2021
End Date
March 10 2023
Last Update
February 2 2024
Active Locations (1)
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1
Baylor Research Institute
Temple, Texas, United States, 76502