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) — DRUG
    norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
  • Placebo — DRUG
    Placebo, 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 Group
    Placebo to Norethindrone acetate (NTA)
  • Active Comparator: Treatment Group
    Norethindrone acetate (NTA)

Primary Outcome Measure

Number of days of bleeding and spotting [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor Research InstituteTempleTexas76502-

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