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

Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™; a Randomized Double-Blinded Placebo-Controlled Trial

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04676061

Enrollment

Registered

2020-12-19

Start date

2021-02-11

Completion date

2023-03-10

Last updated

2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Control, Breakthrough Bleeding, Contraception, Implant, Uterine Bleeding

Keywords

Uterine Hemorrhage, Norethindrone Acetate, Contraceptives

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™.

Interventions

DRUGNorethindrone acetate (NTA)

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 48 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026