Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
Part of paid clinical trials in Temple, Texas.
- Sponsor
- Baylor Research Institute
- Study ID
- NCT04676061
- Phase
- PHASE4
- Status
- Terminated
Conditions
- Birth Control
- Breakthrough Bleeding
- Contraception
- Implant
- Uterine Bleeding
Eligibility Criteria
- Sex
- FEMALE
- Age
- 14 Years - 48 Years
- Healthy Volunteers
- Accepted
Interventions
- Norethindrone acetate (NTA) — DRUGnorethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
- Placebo — DRUGPlacebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
Study Details
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
Key Dates
- Start date
- Feb 11, 2021
- Status verified
- Mar 2023
- Primary completion
- Jul 18, 2022
- Completion
- Mar 10, 2023
Study Design
- Enrollment
- 51 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Control GroupPlacebo to Norethindrone acetate (NTA)
- Active Comparator: Treatment GroupNorethindrone acetate (NTA)
Primary Outcome Measure
Number of days of bleeding and spotting [ Time Frame: 30 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baylor Research Institute | Temple | Texas | 76502 | - |
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