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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    124
  • sponsor
    Baylor Research Institute
Updated on 30 April 2021

Summary

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

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.

Details
Condition Contraception, Contraception, Birth Control, Hemorrhage, Hemorrhage, Disorder of uterus NOS, Uterine Disorders, Vaginal Bleeding, Metrorrhagia, Dysfunctional Uterine Bleeding, implant, Uterine Disorders, Dysfunctional Uterine Bleeding, Birth Control, uterine bleeding, contraceptive method, birth control method, intermenstrual bleeding, breakthrough bleeding, spotting, implant procedure, surgical implantation
Treatment Placebo, Norethindrone acetate (NTA)
Clinical Study IdentifierNCT04676061
SponsorBaylor Research Institute
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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