Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™

Sponsor
Baylor Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04676061
Collaborator
Merck Sharp & Dohme LLC (Industry)
124
1
2
45.6
2.7

Study Details

Study Description

Brief Summary

Effects of norethindrone acetate (NTA) in patients with Nexplanon.

Condition or Disease Intervention/Treatment Phase
  • Drug: Norethindrone acetate (NTA)
  • Drug: Placebo
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

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial
Actual Study Start Date :
Feb 11, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

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

  1. 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

  1. 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

Ages Eligible for Study:
14 Years to 48 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT04676061
Other Study ID Numbers:
  • 020-291
First Posted:
Dec 19, 2020
Last Update Posted:
Apr 20, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Baylor Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2021