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

B

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

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)

Trial contacts and locations

0

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Central trial contact

Joanna Stacey, MD

Data sourced from clinicaltrials.gov

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