ContraceptionNCT05116371
Control of Bleeding on Nexplanon in Latinx Patients
An observational study of Contraception, run by University of Arizona.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- 150 mcg levonorgestrel/30 mcg ethinyl estradiol
- Type of treatment
- Pill or oral medicine
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
The study will be conducted at University of Arizona. Investigators will recruit people seeking Nexplanon placement and willing to enroll. We aim to enroll 144 patients.
Visit 1:
All patients ages 14-24 presenting for contraception services will be screened for potential inclusion. A trained research assistant will conduct a brief patient-centered contraceptive counseling session focusing on patient preferences.
If interested in participating, the patient will be given a card to present to their clinician. During the visit, patient and provider will discuss further method selection including risks, benefits, and alternatives. The clinician will assess for contraindications per the CDC MEC for use of COC or the implant. Screening for pregnancy, sexually transmitted infections, and cervical cancer screening will follow as clinically indicated. If pregnancy test is negative and clinician can be reasonably certain that patient is not pregnant using the CDC Selected Practice Recommendations, the ENG implant will be placed.
After a clinician encounter, the research assistant will consent those interested in participating. Patients will be assigned a unique identification number once they self-select into their exposure group of choice:
- ENG implant with initiation of concurrent COC use for bleeding control at time of insertion
- ENG implant alone with option for "delayed initiation" of COC if bleeding concerns develop
Enrolled patients will complete Demographic Questionnaire and Bleeding Preference Questionnaire.
Enrolled patients in exposure group 1 will receive 6 months COC pills (150 mcg levonorgestrel/30 mcg ethinyl estradiol) and condoms for the first week of back-up method. After 6 months, they will be offered a prescription to continue COC pills. Patients in exposure group 2 will be receive handouts describing how to contact the research team should bleeding concerns develop. A telehealth or in-person visit will be arranged with the research clinicians, during which the patient may opt to start COC pills. A 6 month supply will be provided.
Follow-Up:
Follow-up contact will be weekly for the first 6 months. There will also be 9 and 12 month contact.
Each contact will be a brief text-message survey inquiring about bleeding patterns, pill usage and side effects. The ENG implant will be removed upon request at any time during the study.
Study participation will be completed after the 12 month follow-up survey.
No blood draws will occur during this study.
There is little data available on the adverse effects of ENG implant use and combined COC. This is a common clinical practice to combine use for bothersome bleeding and this study will collect long-term data regarding this practice.
- Conditions
- Contraception
- Being tested
- 150 mcg levonorgestrel/30 mcg ethinyl estradiol
- Keywords
- etonogestrel implant; irregular bleeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 mcg levonorgestrel/30 mcg ethinyl estradiolDrug
Also called combined oral contraceptive (COC)
concurrent use of COC with Nexplanon
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Same day initiation option | 1) ENG implant with initiation of concurrent COC use for bleeding control at time of insertion Receives: 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 Receives: Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding pattern preferences (measurement: questionnaire)
Evaluate the bleeding pattern preferences of people prior to contraception initiation
Measured: 12 months
Secondary outcomes (4)
acceptability (measurement: questionnaire and follow-up surveys)
willingness to initiate concurrent use of COC pills with ENG implant
Measured: 12 months
continuation (measurement: follow-up surveys)
duration of concurrent use of COC pills with ENG implant; continuation of implant
Measured: 12 months
bleeding patterns (measurement: follow-up surveys)
bleeding patterns with concurrent use of COC pills with ENG implant
Measured: 12 months
side effects (measurement: follow-up surveys)
side effects with concurrent use of COC pills with ENG implant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Responsible party
- Principal investigator, Holly Bullock, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116371
- Sponsor's protocol ID
- IRB 2104687928
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Bleeding on Nexplanon in Latinx Patients
- ClinicalTrials.gov ID
- NCT05116371
- Acronym / sponsor ID
- IRB 2104687928
- Conditions
- Contraception
- Keywords
- etonogestrel implant; irregular bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Organon
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be conducted at University of Arizona. Investigators will recruit people seeking Nexplanon placement and willing to enroll. We aim to enroll 144 patients.
Visit 1:
All patients ages 14-24 presenting for contraception services will be screened for potential inclusion. A trained research assistant will conduct a brief patient-centered contraceptive counseling session focusing on patient preferences.
If interested in participating, the patient will be given a card to present to their clinician. During the visit, patient and provider will discuss further method selection including risks, benefits, and alternatives. The clinician will assess for contraindications per the CDC MEC for use of COC or the implant. Screening for pregnancy, sexually transmitted infections, and cervical cancer screening will follow as clinically indicated. If pregnancy test is negative and clinician can be reasonably certain that patient is not pregnant using the CDC Selected Practice Recommendations, the ENG implant will be placed.
After a clinician encounter, the research assistant will consent those interested in participating. Patients will be assigned a unique identification number once they self-select into their exposure group of choice:
- ENG implant with initiation of concurrent COC use for bleeding control at time of insertion
- ENG implant alone with option for "delayed initiation" of COC if bleeding concerns develop
Enrolled patients will complete Demographic Questionnaire and Bleeding Preference Questionnaire.
Enrolled patients in exposure group 1 will receive 6 months COC pills (150 mcg levonorgestrel/30 mcg ethinyl estradiol) and condoms for the first week of back-up method. After 6 months, they will be offered a prescription to continue COC pills. Patients in exposure group 2 will be receive handouts describing how to contact the research team should bleeding concerns develop. A telehealth or in-person visit will be arranged with the research clinicians, during which the patient may opt to start COC pills. A 6 month supply will be provided.
Follow-Up:
Follow-up contact will be weekly for the first 6 months. There will also be 9 and 12 month contact.
Each contact will be a brief text-message survey inquiring about bleeding patterns, pill usage and side effects. The ENG implant will be removed upon request at any time during the study.
Study participation will be completed after the 12 month follow-up survey.
No blood draws will occur during this study.
There is little data available on the adverse effects of ENG implant use and combined COC. This is a common clinical practice to combine use for bothersome bleeding and this study will collect long-term data regarding this practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Same day initiation option | – | Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol1) ENG implant with initiation of concurrent COC use for bleeding control at time of insertion |
| Group 2: Delayed initiation option | – | Drug: 150 mcg levonorgestrel/30 mcg ethinyl estradiol2) ENG implant alone with option for "delayed initiation" of COC if bleeding concerns develop |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150 mcg levonorgestrel/30 mcg ethinyl estradiolAlso: combined oral contraceptive (COC)concurrent use of COC with Nexplanon | Drug | Group 1: Same day initiation option, Group 2: Delayed initiation option |
Primary outcome
bleeding pattern preferences (measurement: questionnaire)
Time frame: 12 months
Evaluate the bleeding pattern preferences of people prior to contraception initiation
4 secondary outcomes
acceptability (measurement: questionnaire and follow-up surveys)
Time frame: 12 months
continuation (measurement: follow-up surveys)
Time frame: 12 months
bleeding patterns (measurement: follow-up surveys)
Time frame: 12 months
side effects (measurement: follow-up surveys)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Holly Bullock, MD, MPH (520-626-6591, hollybullock@obgyn.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding pattern preferences (measurement: questionnaire) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.