← Back to Search

Etonogestrel for Birth Control (LACTO-Rod Trial)

Phase 4
Waitlist Available
Led By Jamie Krashin@salud.unm.edu
Research Sponsored by University of New Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Desire the implant as a method for contraception
Aged 13 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks postpartum.
Awards & highlights

LACTO-Rod Trial Summary

This trial is looking at whether it's better to place the Nexplanon implant immediately after childbirth, or wait 4-6 weeks. There's no difference in breastfeeding 8 weeks after delivery.

Who is the study for?
This study is for English or Spanish-speaking women who have given birth at UNM Hospital after a full-term pregnancy, wish to breastfeed and want the etonogestrel implant (Nexplanon) for birth control. Participants must be 13 years or older, agree to randomization, and have a working phone.Check my eligibility
What is being tested?
The trial examines if getting the Nexplanon implant within the first day after giving birth affects breastfeeding success compared to receiving it 4-6 weeks later. Women will be randomly assigned to one of these two schedules.See study design
What are the potential side effects?
While not specified in this summary, common side effects of Nexplanon may include changes in menstrual periods, mood swings, weight gain, headache, acne, and breast pain.

LACTO-Rod Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I want to use the implant for birth control.
Select...
I am 13 years old or older.

LACTO-Rod Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks postpartum.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks postpartum. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Continuation of breastfeeding.
Time to lactogenesis.
Secondary outcome measures
Exclusive breastfeeding.
Factors associated with breastfeeding discontinuation.
Postpartum bleeding days.
+4 more

LACTO-Rod Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate insertion groupExperimental Treatment2 Interventions
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
Group II: Standard Postpartum Insertion GroupActive Control2 Interventions
Insertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etonogestrel
2016
Completed Phase 4
~550

Find a Location

Who is running the clinical trial?

Society of Family PlanningOTHER
98 Previous Clinical Trials
16,984 Total Patients Enrolled
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,639 Total Patients Enrolled
Jamie Krashin@salud.unm.eduPrincipal InvestigatorUniversity of New Mexico

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary objective of this clinical investigation?

"This clinical trial aims to evaluate the primary outcome of time-to-lactogenesis within 8 weeks postpartum, as well as secondary outcomes including Edinburgh Postnatal Depression Scale (EPDS) scores at 2, 4, 8, 12 and 24 weeks postpartum for assessing postpartum mood; a four point Likert scale questionnaire to compare factors associated with discontinuation of breastfeeding between immediate vs. standard groups; and an exclusive breastfeeding trichotomous question given in follow up questionnaires administered at 2,4,8,12 and 24 week intervals."

Answered by AI

Has Etonogestrel received the green light from the Food and Drug Administration?

"Based on the Phase 4 status of Etonogestrel, our team has assigned a safety rating of 3. This signifies that this particular drug is approved for use in clinical practice."

Answered by AI

Have any other experiments with Etonogestrel been conducted previously?

"Initially investigated by VL Medi Oy in 2011, etonogestrel has now undergone 44 clinical trials. Currently there are 8 studies actively recruiting participants, primarily at sites located in Albuquerque, New mexico."

Answered by AI

What conditions is Etonogestrel frequently utilized to treat?

"Etonogestrel is an efficacious treatment for contraception, contraceptive implant therapy, and reproductive age management."

Answered by AI

Is enrollment for this clinical trial open at the present time?

"This clinical trial is actively recruiting participants, as evidenced by the listing on clinicaltrials.gov which was first posted June 3rd 2019 and most recently updated August 4th 2022."

Answered by AI

Is this research innovative in nature?

"Research into Etonogestrel began in 2011, with a trial sponsored by Merck Sharp & Dohme LLC. After the successful completion of this initial study involving 90 patients, Phase 4 drug approval was granted for the medication. At present there are 8 separate clinical trials being conducted in 59 cities and 5 countries utilizing Etonogestrel."

Answered by AI

How many participants will be taking part in this trial?

"Indeed, according to clinicaltrials.gov, this medical study is still actively seeking participants. Initially posted on June 3rd 2019 and updated as recently as August 4th 2022, the trial intends to recruit 150 patients from 2 different sites."

Answered by AI
Recent research and studies
~26 spots leftby Apr 2025