Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
NCT ID: NCT04676061
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
51 participants
INTERVENTIONAL
2021-02-11
2023-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Control Group
Placebo to Norethindrone acetate (NTA)
Placebo
Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
Treatment Group
Norethindrone acetate (NTA)
Norethindrone acetate (NTA)
norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
Interventions
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Norethindrone acetate (NTA)
norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
Placebo
Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
48 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Joanna Stacey, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Reserach Institute
Locations
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Baylor Research Institute
Temple, Texas, United States
Countries
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Other Identifiers
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020-291
Identifier Type: -
Identifier Source: org_study_id
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