Control of Bleeding on Nexplanon in Latinx Patients

NCT05116371 | Unknown FDA Drug

• 1 other identifier: IRB 2104687928
• Study Type: observational
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, researchers want to find out more about how the Etonogestrel (ENG) contraceptive implant device (also known as Nexplanon) changes people's periods. Study subjects will self select into an exposure group- starting combined hormonal contraceptive pills (COC) on the same day as Nexplanon placement or a "delayed initiation" of COC when/if bleeding concerns develop. Patients will be followed for 12 months.

Conditions

Contraception

Keywords

etonogestrel implant; irregular bleeding

Outcome Measures

Primary Outcomes (1)

• bleeding pattern preferences (measurement: questionnaire)

  Evaluate the bleeding pattern preferences of people prior to contraception initiation

  12 months

Secondary Outcomes (4)

• acceptability (measurement: questionnaire and follow-up surveys)

  12 months

• continuation (measurement: follow-up surveys)

  12 months

• bleeding patterns (measurement: follow-up surveys)

  12 months

• side effects (measurement: follow-up surveys)

  12 months

Study Arms (2)

Group 1: Same day initiation option

1\) ENG implant with initiation of concurrent COC use for bleeding control at time of insertion

Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol

Group 2: Delayed initiation option

2\) ENG implant alone with option for "delayed initiation" of COC if bleeding concerns develop

Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol

Interventions

150 mcg levonorgestrel/30 mcg ethinyl estradiol DRUG

concurrent use of COC with Nexplanon

Also known as: combined oral contraceptive (COC)

Group 1: Same day initiation option; Group 2: Delayed initiation option

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

University of Arizona is a federally designated Hispanic Serving Institution with 28% of its undergraduate population self-identifying as Hispanic. The Department of Obstetrics and Gynecology provides a large proportion of contraceptive care in southern Arizona and is situated to serve as an incubator for participatory research with our Latinx community. From 7/1/2018 - 7/1/2019, a total of 340 patients had implants placed, with 50% of those patients identifying as Latinx or Hispanic. Over a 24 months enrollment period, we estimate that approximately 600 people will want an ENG implant, and through screening that 50% will meet inclusion criteria (300), and 50% will consent to participate (150). Our target for enrollment in 144 (72 non-Latinx and 72 Latinx).

You may qualify if:

• Fluent in English or Spanish Access to a cellular phone with text messaging and internet capabilities Capable of and willing to receive cellular phone text message Interest in preventing pregnancy for at least 12 months with the ENG implant Interest in use of COC pills with concurrent with ENG implant use Negative urine pregnancy test

You may not qualify if:

• Contraindication to COC pills or ENG implant as determined by the Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use (CDC MEC) Less than 4 weeks postpartum

Sponsors & Collaborators

• University of Arizona: lead
• Organon: collaborator

MeSH Terms

Interventions

Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Central Study Contacts

Holly Bullock, MD, MPH

CONTACT

520-626-6591; hollybullock@obgyn.arizona.edu

Shamam Hashim, BS

CONTACT

520-626-6591; shamamhashim@obgyn.arizona.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of OBGYN

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share