Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
Primary Purpose
Birth Control, Contraception, Implant
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Norethindrone acetate (NTA)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Birth Control focused on measuring Uterine Hemorrhage, Norethindrone Acetate, Contraceptives
Eligibility 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
Sites / Locations
- Baylor Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control Group
Treatment Group
Arm Description
Placebo to Norethindrone acetate (NTA)
Norethindrone acetate (NTA)
Outcomes
Primary Outcome Measures
Number of days of bleeding and spotting
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
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.
Full Information
NCT ID
NCT04676061
First Posted
December 11, 2020
Last Updated
April 19, 2021
Sponsor
Baylor Research Institute
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04676061
Brief Title
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
Official Title
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effects of norethindrone acetate (NTA) in patients with Nexplanon.
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™.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Control, Contraception, Implant, Breakthrough Bleeding, Uterine Bleeding
Keywords
Uterine Hemorrhage, Norethindrone Acetate, Contraceptives
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo to Norethindrone acetate (NTA)
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
Norethindrone acetate (NTA)
Intervention Type
Drug
Intervention Name(s)
Norethindrone acetate (NTA)
Intervention Description
norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
Primary Outcome Measure Information:
Title
Number of days of bleeding and spotting
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Quality of life measurements
Description
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.
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Stacey, MD
Phone
254-724-4031
Email
Joanna.Stacey@BSWHealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Stacey, MD
Organizational Affiliation
Baylor Reserach Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Research Institute
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna Stacey, MD
Email
Joanna.Stacey@BSWHealth.org
First Name & Middle Initial & Last Name & Degree
Richard Vargas
Email
Richard.Vargas@BSWHealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
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