Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
Study Details
Study Description
Brief Summary
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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™.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Placebo Comparator: Control Group Placebo to Norethindrone acetate (NTA) |
Drug: Placebo
Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
|
Active Comparator: Treatment Group Norethindrone acetate (NTA) |
Drug: Norethindrone acetate (NTA)
norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
|
Outcome Measures
Primary Outcome Measures
- Number of days of bleeding and spotting [30 days]
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
Secondary Outcome Measures
- Quality of life measurements [30 days]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Baylor Research Institute | Temple | Texas | United States | 76502 |
Sponsors and Collaborators
- Baylor Research Institute
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Joanna Stacey, MD, Baylor Reserach Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 020-291