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New treatment option for Contraception
Official title Etonogestrel Implant as Emergency Contraception
ClinicalTrials.gov ID: NCT05237141
What this study is testing
What is Etonogestrel implant?
Etonogestrel implant is an investigational medicine, being studied as a potential treatment for contraception.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The investigators propose a single site, single arm, open label mechanism of action pharmacodynamic pilot study of etonogestrel implant insertion prior to an luteinizing hormone (LH) surge. The investigators will evaluate ovulation rates via serum levels of reproductive hormones and transvaginal ultrasound findings following placement of an etonogestrel implant once the dominant follicle reaches a size of 15mm or greater, but prior to an LH surge, in persons with prior documented regular cycles and confirmed ovulation.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- BMI less than or equal to 28kg/m2
- Intact uterus with at least one ovary
- Regular menstrual cycles that occur every 21-35 days
- If patient is postpartum or post-second trimester abortion, 3 menses (2 cycles) must have occurred prior to enrollment
- If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment
You likely can't join if
- Have a known hypersensitivity or contraindications to etonogestrel.
- Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report)
- Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.
- Uncontrolled thyroid disorder.
- Use of long-acting injectable hormonal contraceptive within the past 9 months
- Current use of hormonal oral, patch, intravaginal, or intrauterine contraception
See the full eligibility criteria
- BMI less than or equal to 28kg/m2
- Intact uterus with at least one ovary
- Regular menstrual cycles that occur every 21-35 days
- If patient is postpartum or post-second trimester abortion, 3 menses (2 cycles) must have occurred prior to enrollment
- If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment
- Desires insertion of an etonogestrel contraceptive implant for contraception
- Not currently pregnant or trying to become pregnant
- Willing to abstain from medications and supplements known to induce/inhibit CYP3A4 during the study
- Have a known hypersensitivity or contraindications to etonogestrel.
- Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report)
- Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.
- Uncontrolled thyroid disorder.
- Use of long-acting injectable hormonal contraceptive within the past 9 months
- Current use of hormonal oral, patch, intravaginal, or intrauterine contraception
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.