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

NCT04676061 | Terminated Phase 4 FDA Drug

• 1 other identifier: 020-291
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Birth Control; Contraception; Implant; Breakthrough Bleeding; Uterine Bleeding

Keywords

Uterine Hemorrhage; Norethindrone Acetate; Contraceptives

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (1)

• Quality of life measurements

  30 days

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Placebo to Norethindrone acetate (NTA)

Drug: Placebo

Treatment Group

ACTIVE COMPARATOR

Norethindrone acetate (NTA)

Drug: Norethindrone acetate (NTA)

Interventions

Norethindrone acetate (NTA) DRUG

norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks

Treatment Group

Placebo DRUG

Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks

Control Group

Eligibility Criteria

• Age: 14 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Baylor Research Institute

Temple, Texas, 76502, United States

Location

MeSH Terms

Conditions

Metrorrhagia; Uterine Hemorrhage

Interventions

Norethindrone Acetate

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Joanna Stacey, MD

  Baylor Reserach Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 19, 2020
• Study Start: February 11, 2021
• Primary Completion: July 18, 2022
• Study Completion: March 10, 2023
• Last Updated: February 2, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)