Clinical trial

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

NCT04676061

Name

020-291

Description

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

Trial arms

Trial start

2021-02-11

Estimated PCD

2022-07-18

Trial end

2023-03-10

Status

Terminated

Phase

Early phase I

Treatment

Norethindrone acetate (NTA)

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

Arms:

Treatment Group

Placebo

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

Arms:

Control Group

Size

Primary endpoint

Number of days of bleeding and spotting

30 days

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 51, 'type': 'ACTUAL'}}

Updated at

2024-02-02

1 organization

1 product

1 drug

5 indications

Organization

Baylor Research Institute

Product

Norethindrone acetate

Indication

Birth Control