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Progestin

ENG Implant + Ulipristal Acetate for Birth Control

Q: Can octogenarians take part in this research?

According to the eligibility requirements listed, the patients recruited for this trial must be between 18-35 years old. There are 22 clinical trials that allow for people who are under 18 and 16 for patients who are over 65.

Q: Does my health history meet the requirements to join this research project?

This ongoing clinical trial is looking for 40 participants that use contraception and fit the following profile: 18-35 years old, healthy women, English-speakers, a Body Mass Index below 30 kg/m2, no known contraindication to the study medications, not pregnant or at risk of <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a>, able to comply with study requirements, and willing to avoid pregnancy for the duration of the trial.

Q: How many individuals have signed up to be a part of this research project?

This study is not recruiting at the moment. The date when this study was first posted was September 4th, 2020 and the date of the most recent edit was November 1st, 2022. There are currently 63 other trials related to contraception that are actively recruiting participants and 2 trials for ENG Implant alone that are admitting participants.

Q: Does this study with the ENG Implant stand alone, or has this been tested before?

There are presently 2 ENG Implant clinical trials underway. None of these research projects have reached Phase 3 yet. Most of the research is being conducted in Salt Lake City, <a href="https://www.withpower.com/clinical-trials/utah">Utah</a>; however, there are 2 other locations running similar trials.

Q: Are there still vacancies in this research program for willing test subjects?

The listing for this trial on clinicaltrials.gov shows that it is not presently recruiting. The trial was posted on September 4th, 2020, and updated on November 1st, 2020. There are, however, 65 other trials enrolling patients right now.

Phase < 1

Waitlist Available

Led By Lori Gawron, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 14

Awards & highlights

Study Summary

This trial will assess the effects of the etonogestrel implant alone and the implant inserted with same-day oral ulipristal acetate usage on ovarian activity.

Who is the study for?

This trial is for healthy women aged 18-35, with a BMI under 30, not pregnant or at risk of pregnancy, and who have regular menstrual cycles. They must avoid pregnancy during the study and be willing to follow all requirements. Women using hormonal contraception recently or certain medications are excluded.Check my eligibility

What is being tested?

The study tests if starting an ENG implant (birth control device) on the same day as taking oral ulipristal acetate (UPA) affects ovarian activity compared to just the implant alone. Participants will undergo daily monitoring for one week to see if there's any ovulation.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to birth control implants like soreness where it's inserted, headaches, weight gain, acne, mood swings or breast pain; UPA might cause mild stomach upset or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of ovulation with Implant and same day UPA

Incidence of ovulation with Implant-alone

Secondary outcome measures

Timing of ovulation with implant alone

Timing of ovulation with implant and oral UPA

Trial Design

2Treatment groups

Active Control

Group I: ENG Implant plus oral UPAActive Control2 Interventions

Women will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.

Group II: ENG Implant aloneActive Control1 Intervention

Women will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,934 Total Patients Enrolled

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,682 Total Patients Enrolled

Lori Gawron, MDPrincipal InvestigatorUniversity of Utah

1 Previous Clinical Trials

297 Total Patients Enrolled

Media Library

ENG implant (Progestin) Clinical Trial Eligibility Overview. Trial Name: NCT04291001 — Phase < 1

Birth Control Research Study Groups: ENG Implant plus oral UPA, ENG Implant alone

Birth Control Clinical Trial 2023: ENG implant Highlights & Side Effects. Trial Name: NCT04291001 — Phase < 1

ENG implant (Progestin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04291001 — Phase < 1

Frequently Asked Questions

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

Can octogenarians take part in this research?

"According to the eligibility requirements listed, the patients recruited for this trial must be between 18-35 years old. There are 22 clinical trials that allow for people who are under 18 and 16 for patients who are over 65."

Answered by AI

Does my health history meet the requirements to join this research project?

"This ongoing clinical trial is looking for 40 participants that use contraception and fit the following profile: 18-35 years old, healthy women, English-speakers, a Body Mass Index below 30 kg/m2, no known contraindication to the study medications, not pregnant or at risk of pregnancy, able to comply with study requirements, and willing to avoid pregnancy for the duration of the trial."

Answered by AI

How many individuals have signed up to be a part of this research project?

"This study is not recruiting at the moment. The date when this study was first posted was September 4th, 2020 and the date of the most recent edit was November 1st, 2022. There are currently 63 other trials related to contraception that are actively recruiting participants and 2 trials for ENG Implant alone that are admitting participants."

Answered by AI

Does this study with the ENG Implant stand alone, or has this been tested before?

"There are presently 2 ENG Implant clinical trials underway. None of these research projects have reached Phase 3 yet. Most of the research is being conducted in Salt Lake City, Utah; however, there are 2 other locations running similar trials."

Answered by AI

Are there still vacancies in this research program for willing test subjects?

"The listing for this trial on clinicaltrials.gov shows that it is not presently recruiting. The trial was posted on September 4th, 2020, and updated on November 1st, 2020. There are, however, 65 other trials enrolling patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ovarian Function With ENG Implant and UPA Use

2020. "Ovarian Function With ENG Implant and UPA Use". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04291001.