Use of Norethindrone Acetate for Management of Bleeding Associated With the Etonogestrel Contraceptive Implant

NCT02353247 | Completed Results

• 1 other identifier: 14-N0278
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to confirm that oral progesterone is an effective way to manage bothersome bleeding; thus increasing the rate of continuation of the etonogestrel contraceptive implant in adolescents.

Conditions

Etonogestrel Contraceptive Implant, Bothersome Bleeding

Outcome Measures

Primary Outcomes (1)

• Impact of Aygestin (and Dose of Aygestin) on the Management of Bothersome Bleeding Associated With the Etonogestrel Contraceptive Implant

  "Bothersome bleeding" was defined per WHO classification as either frequent bleeding (greater than 5 bleeding-spotting episodes in a 90-day reference period) or prolonged bleeding (any bleeding-spotting episode, uninterrupted, lasting greater than 14 days in a 90-day reference period) The scale used was derived from the WHO classification system: Bleeding Day (assigned value = 1) Spotting Day (assigned value = .5) Bleeding Free Day (assigned value = 0) Prefer not to answer today (assigned value = missing) Higher scores (average of the time period) indicate more bothersome bleeding; low scores indicate less bothersome bleeding. Less bothersome bleeding is the desired outcome. Note, the scale is not a published scale but rather was constructed for this study.

  Initial 3 months of baseline collection (medicine free); For intervention group, 3 months of medicine, followed by 3 months of medicine free; For control group, 6 months of medicine free.

Study Arms (1)

Norethindrone acetate (aygestin)

OTHER

Norethindrone acetate (aygestin) will be used to manage bothersome bleeding. Patients will be prescribed aygestin 5 mg by mouth twice daily for one month, followed by aygestin 5 mg by mouth once daily for two months. Medication will then be discontinued. Patients will be evaluated in the office three months after medication initiation, and then again six months after medication initiation. If the patient is unable to take norethindrone acetate (aygestin) due to medical contraindications or cost, they will receive medroxyprogesterone acetate (provera) 10 mg once daily as alternate oral progesterone. Figure 1 below highlights the study

Drug: Norethindrone acetate

Interventions

Norethindrone acetate DRUG

Also known as: Aygestin

Norethindrone acetate (aygestin)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Norton Healthcare: lead

Study Sites (1)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

Norethindrone Acetate

Intervention Hierarchy (Ancestors)

Norethindrone; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Professor Andrew Scott LaJoie, PhD, statistician on project
• Organization: University of Louisville

lajoie@louisville.edu

502-852-1879

Study Officials

• Scott LaJoie, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: February 2, 2015
• Study Start: August 1, 2015
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: March 16, 2022
• Results First Posted: March 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)