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

Baylor Scott and White Health (BSWH)

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Placebo; Drug: Norethindrone acetate (NTA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04676061

020-291

Details and patient eligibility

About

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

Full 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™.

Enrollment: 51 patients

Sex: Female

Ages: 14 to 48 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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51 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Placebo to Norethindrone acetate (NTA)

Treatment:

Drug: Placebo

Treatment Group

Active Comparator group

Description:

Norethindrone acetate (NTA)

Treatment:

Drug: Norethindrone acetate (NTA)