A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)

A Phase 3, Open-label, Multi-center, Single Arm Study to Assess Contraceptive Efficacy and Safety of the Etonogestrel (MK-8415) Implant During Extended Use From 3 Years After Insertion in Females 35 Years of Age or Younger

The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.

Study Overview

• Status: Active, not recruiting
• Conditions: Contraception
• Intervention / Treatment: Combination product: Radiopaque Etonogestrel (ENG) Implant

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Cooperativa de Facultad Medica SANACOOP (Site 0310)
  • Cidra, Puerto Rico, 00739
    • Advance Medical Concept PSC (Site 0313)
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico Inc (Site 0302)
  • San Juan, Puerto Rico, 00927
    • FDI Clinical Research (Site 0305)
  • San Juan, Puerto Rico, 00935
    • La Alianza Hispana para Investigacion Clinica y Traslacional - LA ALIANZA (Site 0300)
• United States
  • Alabama
    • Alabaster, Alabama, United States, 35235
      • Alabama Clinical Therapeutics (Site 0224)
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics (Site 0222)
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Desert Star Family Planning (Site 0193)
    • Phoenix, Arizona, United States, 85032
      • Precision Trials (Site 0187)
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research Tucson (Site 0134)
  • California
    • Los Angeles, California, United States, 90010
      • Essential Access Health (Site 0163)
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research Inc (Site 0105)
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles (Site 0119)
    • Sacramento, California, United States, 95817
      • University of California, Davis (Site 0124)
    • Stanford, California, United States, 94305
      • Stanford University (Site 0112)
  • Colorado
    • Denver, Colorado, United States, 80207
      • Planned Parenthood of the Rocky Mountains (Site 0196)
    • Denver, Colorado, United States, 80230
      • Comprehensive Womens Health Center (Site 0194)
    • Lakewood, Colorado, United States, 80228
      • Physicians' Research Options, LLC (Site 0166)
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Planned Parenthood of Southern New England (Site 0143)
  • Florida
    • Jacksonville, Florida, United States, 32207
      • University Of Florida (Site 0144)
    • Panama City, Florida, United States, 32405
      • Emerald Coast Obstetrics and Gynecology (Site 0203)
    • Sweetwater, Florida, United States, 33172
      • Lenus Research & Medical Group Llc (Site 0102)
    • West Palm Beach, Florida, United States, 33409
      • Comprehensive Clinical Trials LLC (Site 0101)
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research (Site 0111)
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rosemark (Site 0177)
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Planned Parenthood of Illinois (PPIL) (Site 0200)
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University (Site 0220)
  • Iowa
    • Ames, Iowa, United States, 50010-3014
      • McFarland Clinic, PC (Site 0217)
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Cypress Medical Research Center (Site 0226)
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Southern Clinical Research Associates (Site 0219)
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center (Site 0225)
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center (Site 0167)
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood League of Massachusetts (Site 0135)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine (Site 0108)
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group, LLC (Site 0198)
  • Minnesota
    • Minneapolis, Minnesota, United States, 55408
      • Planned Parenthood of North Central States (PPNCS) (Site 0113)
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Metro Jackson OBGYN/SKYCRNG (Site 0233)
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Planned Parenthood of the Saint Louis Region & Southwest Missouri (Site 0158)
    • Saint Louis, Missouri, United States, 63108
      • Washington University (Site 0129)
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Women's Clinic of Lincoln PC (Site 0156)
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Office of Edmond Pack, MD (Site 0168)
    • Las Vegas, Nevada, United States, 89123
      • Clinical Research Center of Nevada, LLC (Site 0179)
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Capital Health OB/GYN- Lawrenceville (Site 0190)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials (Site 0210)
    • Albuquerque, New Mexico, United States, 87111
      • Bosque Women's Care (Site 0211)
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center (Site 0103)
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai (Site 0155)
    • New York, New York, United States, 10032
      • Columbia Univ. Medical Center (Site 0118)
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Carolina Women's Research and Wellness Center (Site 0154)
    • Fayetteville, North Carolina, United States, 28303
      • Carolina Institute for Clinical Research, LLC (Site 0215)
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center (Site 0159)
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research, Cincinnati (Site 0230)
    • Columbus, Ohio, United States, 43210
      • The Ohio State University (Site 0176)
    • Englewood, Ohio, United States, 45322
      • HWC Women's Research Center (Site 0199)
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University Hospital (Site 0128)
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • OB/GYN Associates of Erie (Site 0183)
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh - Magee Womens Hospital (Site 0100)
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research (Site 0133)
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center Knoxville (Site 0218)
    • Memphis, Tennessee, United States, 38120
      • WR-Medical Research Center of Memphis, LLC (Site 0229)
  • Texas
    • Beaumont, Texas, United States, 77702
      • Gadolin Research (Site 0232)
    • Fort Worth, Texas, United States, 76104
      • Signature Gyn Services (Site 0201)
    • Houston, Texas, United States, 77023
      • Planned Parenthood of the Gulf Coast (Site 0106)
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center (Site 0178)
    • Houston, Texas, United States, 77058
      • Centex Studies, Inc. (Site 0171)
    • Pearland, Texas, United States, 77030
      • Advances in Health, Inc. (Site 0209)
    • San Antonio, Texas, United States, 78229
      • Tekton Research - Floyd Curl Drive (Site 0228)
  • Utah
    • Draper, Utah, United States, 84020
      • Physicians' Research Options, LLC (Site 0197)
    • Pleasant Grove, Utah, United States, 84062
      • Physicians' Research Options, LLC (Site 0204)
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research (Site 0174)
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research Inc (Site 0162)
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School (Site 0146)
  • Washington
    • Cheney, Washington, United States, 99004
      • Multicare Health System Institute for Research and Innovation (Site 0188)
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology (Site 0149)
    • Seattle, Washington, United States, 98105
      • University of Washington Medical Center (Site 0160)
    • Seattle, Washington, United States, 98122
      • Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky (Site 0110)
    • Spokane, Washington, United States, 99207
      • North Spokane Women's Clinic (Site 0137)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 35 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Not diagnosed with perimenopause or menopause.
• Heterosexually active with a partner who is not known to be subfertile, sterilized, or infertile, and is seeking contraception for pregnancy.
• Palpable intact ENG implant in the upper inner-arm for 36 months from the date of insertion at the time of enrollment, and has documentation of the insertion date (for example, Nexplanon user card or medical record completed on the date of insertion).
• Does not desire a pregnancy within the 24 months after enrollment, is willing to continue use of the implant for an additional 24 months, and is not intending to use any other form of contraception (eg, condoms) from enrollment until after implant removal at 24 months post enrollment.
• Good physical and mental health in the medical judgment of the investigator.
• History of regular menstrual cycles of 21 to 35 days before the insertion of the ENG implant or before hormonal contraceptive use (which may have preceded the current implant use).
• Able and willing to adhere to all required study procedures, including study visits and eDiary entries, and not planning to relocate during the study.

Exclusion Criteria:

• Conceived a pregnancy during use of the current implant or a past contraceptive implant.
• Known or suspected pregnancy at the time of screening or enrollment visit.
• History of subfertility or infertility.
• Breastfeeding.
• Untreated gonorrhea, chlamydia, or trichomonas or symptomatic vaginitis/cervicitis.
• Significantly abnormal cervical cytology (Pap) or pathology results either at screening or documented in the 36-month period prior to enrollment.
• Current use of an intrauterine device/intrauterine system (IUD/IUS).
• Presence of more than one ENG implant.
• Use of daily/monthly hormonal contraceptives, sex steroids, or GnRH agonist/antagonist within 3 months prior to enrollment.
• Use of injectable hormonal contraceptive with 3-month duration within 9 months prior to enrollment.
• Use of injectable GnRH agonist with 3-month duration within 10 months prior to enrollment .
• Use of medications that induce liver enzymes within 2 months prior to enrollment.
• Untreated or unresolved vaginal bleeding or spotting attributable to underlying pathology in the 12 months before screening.
• Frequent, prolonged, or excessive vaginal bleeding/spotting in the 12 months prior to screening which has not been evaluated to detect underlying pathology.
• History of venous thromboembolism or arterial thromboembolism, transient ischemic attack, angina pectoris, or claudication.
• Any condition associated with an increased risk of venous thromboembolism.
• Uncontrolled or severe hypertension at screening visit.
• Clinically significant liver disease, including active viral hepatitis or cirrhosis.
• History of malignancy within 5 years before screening, except treated skin cancer.
• History of sex steroid-influenced malignancies (eg, genital organs, breasts).
• History or presence of liver tumors (benign or malignant).
• Known allergy/sensitivity or contraindication to the ENG implant or lidocaine with epinephrine.
• History of drug or alcohol abuse or dependence within 24 months prior to enrollment. Routine use of alcohol or marijuana that is not considered abuse or dependence is not exclusionary.
• Use of an investigational drug within 2 months prior to enrollment. Long-term follow up of an investigational compound for COVID-19 is allowed 2 months after the last administered dose.
• Staff or immediate family members of the investigational site or Sponsor directly involved with this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENG implant; Participants will have the ENG 68 mg implant inserted and in place for 36 months before enrollment. The ENG implant will remain in place for an additional 24 months.	Combination product: Radiopaque Etonogestrel (ENG) Implant; 68 mg subdermal implant; Other Names: Nexplanon; Org 32222; Implanon-NXT; SCH900415; MK-8415

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Rate (Pearl Index) for At Risk Cycles During Extended-Duration Use	The Pearl Index is expressed as the number of on-treatment pregnancies per 100 woman-years of exposure. An on-treatment pregnancy is defined as a confirmed pregnancy with an estimated date of conception 36 months to 60 months since the date of implant insertion. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "at risk" cycles for conception will be included in this Pearl Index calculation. An at risk cycle is defined as a cycle during which participants with ENG implant had affirmed heterosexual intercourse without the use of additional contraception.	Up to 24 months
Pregnancy Rate (Pearl Index) for Alternative At Risk Cycles During Extended-Duration Use	The Pearl Index is expressed as the number of on-treatment pregnancies per 100 woman-years of exposure. An on-treatment pregnancy is defined as a confirmed pregnancy conceived with an estimated date of conception 36 months to 60 months since the date of implant insertion. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "alternative at risk" cycles will be included in this Pearl Index calculation. An alternative at risk cycle is defined as a cycle in which participants with ENG implant did not use additional contraception, but without the requirement for affirmed heterosexual intercourse.	Up to 24 months
Number of Participants Who Experience One or More Adverse Events During Extended-Duration Use	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 27 months
Number of Participants Who Discontinue Treatment (Implant Removed) Due to an Adverse Event During Extended-Duration Use	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Rate (Pearl Index) for At Risk Cycles During Year 4 of Implant Use	Pearl Index will be calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "at risk" cycles for conception will be included in this Pearl Index calculation. An at risk cycle is defined as a cycle during which participants with ENG implant had affirmed heterosexual intercourse without the use of additional contraception.	Up to 12 months
Pregnancy Rate (Pearl Index) for At Risk Cycles During Year 5 of Implant Use	Pearl Index will be calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "at risk" cycles for conception will be included in this Pearl Index calculation. An at risk cycle is defined as a cycle during which participants with ENG implant had affirmed heterosexual intercourse without the use of additional contraception.	Up to 12 months
Cumulative Pregnancy Rate During 5 Years of Implant Use	Cumulative on-treatment pregnancy rate will be calculated based on life table analysis over 5 years of implant use.	Up to 60 months (From 3 years prior to study entry to 2 years after study entry)
Cumulative Pregnancy Rate During 4 Years of Implant Use	Cumulative on-treatment pregnancy rate will be calculated based on life table analysis over 4 years of implant use.	Up to 48 months (From 3 years prior to study entry to 1 year after study entry)
Pregnancy Rate (Pearl Index) for At Risk Cycles During 5 Years of Implant Use	Pearl Index will be calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "at risk" cycles for conception will be included in this Pearl Index calculation. An at risk cycle is defined as a cycle during which participants with ENG implant had affirmed heterosexual intercourse without the use of additional contraception. The number of at-risk cycles of use for each of the 3 years prior to study entry will be estimated.	Up to 60 months (From 3 years prior to study entry to 2 years after study entry)
Pregnancy Rate (Pearl Index) for Alternative At Risk Cycles During 5 Years of Implant Use	Pearl Index will be calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. Exposure in 100 woman-years is equal to the number of cycles of use/1300, and one woman-year is defined as a period of 13 treatment cycles, each 28 days long. Only "alternative at risk" cycles will be included in this Pearl Index calculation. An alternative at risk cycle is defined as a cycle in which participants with ENG implant did not use additional contraception, but without the requirement for affirmed heterosexual intercourse. The number of alternative at risk cycles of use for each of the 3 years prior to study entry will be estimated.	Up to 60 months (From 3 years prior to study entry to 2 years after study entry)
Number of Bleeding Days During Extended-Duration Use as Assessed in 90-day Reference Periods	Participants will record daily vaginal bleeding in an electronic diary. A bleeding day is defined as any day (24 hours) with bloody vaginal discharge requiring more than one sanitary product (i.e., pad, panty liner, tampon, or menstrual cup) or, if only a menstrual cup is used, more than 5 mL of blood accumulates. Number of bleeding days will be assessed per 90-day reference period (RP).	Up to 24 months
Number of Spotting Days During Extended-Duration Use as Assessed in 90-day Reference Periods	Participants will record daily vaginal spotting in an electronic diary. A spotting day is defined as any day (24 hours) with bloody vaginal discharge requiring at most one sanitary product (i.e. pad, panty liner, tampon, or menstrual cup containing 5 ml [inclusive] or less of blood). Number of spotting days will be assessed per 90-day reference period (RP).	Up to 24 months
Number of Bleeding and/or Spotting Days During Extended-Duration Use as Assessed in 90-day Reference Periods	Participants will record daily vaginal bleeding and/or spotting in an electronic diary. A bleeding day is defined as any day (24 hours) with bloody vaginal discharge requiring more than one sanitary product (i.e., pad, panty liner, tampon, or menstrual cup) or, if only a menstrual cup is used, more than 5 mL of blood accumulates. A spotting day is defined as any day (24 hours) with bloody vaginal discharge requiring at most one sanitary product (i.e. pad, panty liner, tampon, or menstrual cup containing 5 ml [inclusive] or less of blood). Number of bleeding and/or spotting days will be assessed per 90-day reference period (RP).	Up to 24 months
Mean Length of Bleeding and/or Spotting Episodes During Extended-Duration Use as Assessed in 90-day Reference Periods	Participants will record daily vaginal bleeding and/or spotting in an electronic diary (eDiary). A bleeding day is defined as any day (24 hours) with bloody vaginal discharge requiring more than one sanitary product (i.e., pad, panty liner, tampon, or menstrual cup) or, if only a menstrual cup is used, more than 5 mL of blood accumulates. A spotting day is defined as any day (24 hours) with bloody vaginal discharge requiring at most one sanitary product (i.e. pad, panty liner, tampon, or menstrual cup containing 5 ml [inclusive] or less of blood). A bleeding and/or spotting episode is defined as one or more consecutive days during which bleeding and/or spotting is recorded in the eDiary, bounded bleeding/spotting-free days.	Up to 24 months
Percentage of Participants per 90-day Reference Period with Amenorrhea During Extended-Duration Use	Participants will record daily vaginal bleeding and/or spotting in an electronic diary (eDiary). Amenorrhea is defined as no bleeding or spotting recorded in the eDiary per 90-day reference period (RP).	Up to 24 months
Percentage of Participants per 90-Day Reference Period with Infrequent Bleeding and/or Spotting During Extended-Duration Use	Participants will record daily vaginal bleeding and/or spotting in an electronic diary (eDiary). A bleeding day is defined as any day (24 hours) with bloody vaginal discharge requiring more than one sanitary product (i.e., pad, panty liner, tampon, or menstrual cup) or, if only a menstrual cup is used, more than 5 mL of blood accumulates. A spotting day is defined as any day (24 hours) with bloody vaginal discharge requiring at most one sanitary product (i.e. pad, panty liner, tampon, or menstrual cup containing 5 ml [inclusive] or less of blood). Infrequent bleeding and/or spotting is defined as less than 3 episodes of bleeding and/or spotting per 90-day reference period (RP).	Up to 24 months
Percentage of Participants per 90-Day Reference Period with Frequent Bleeding and/or Spotting During Extended-Duration Use	Participants will record daily vaginal bleeding and/or spotting in an electronic diary (eDiary). A bleeding day is defined as any day (24 hours) with bloody vaginal discharge requiring more than one sanitary product (i.e., pad, panty liner, tampon, or menstrual cup) or, if only a menstrual cup is used, more than 5 mL of blood accumulates. A spotting day is defined as any day (24 hours) with bloody vaginal discharge requiring at most one sanitary product (i.e. pad, panty liner, tampon, or menstrual cup containing 5 ml [inclusive] or less of blood). Frequent bleeding and/or spotting is defined as more than 5 episodes of bleeding and/or spotting per 90-day reference period (RP).	Up to 24 months
Percentage of Participants per 90-Day Reference Period with Normal Frequency Bleeding and/or Spotting During Extended-Duration Use	Participants will record daily vaginal bleeding and/or spotting in an electronic diary (eDiary). A bleeding day is defined as any day (24 hours) with bloody vaginal discharge requiring more than one sanitary product (i.e., pad, panty liner, tampon, or menstrual cup) or, if only a menstrual cup is used, more than 5 mL of blood accumulates. A spotting day is defined as any day (24 hours) with bloody vaginal discharge requiring at most one sanitary product (i.e. pad, panty liner, tampon, or menstrual cup containing 5 ml [inclusive] or less of blood). Normal frequency of bleeding and/or spotting is defined as 3 to 5 episodes of bleeding and/or spotting per 90-day reference period (RP).	Up to 24 months
Percentage of Participants per 90-Day Reference Period with Prolonged Bleeding and/or Spotting During Extended-Duration Use	Participants will record daily vaginal bleeding and/or spotting in an electronic diary (eDiary). A bleeding day is defined as any day (24 hours) with bloody vaginal discharge requiring more than one sanitary product (i.e., pad, panty liner, tampon, or menstrual cup) or, if only a menstrual cup is used, more than 5 mL of blood accumulates. A spotting day is defined as any day (24 hours) with bloody vaginal discharge requiring at most one sanitary product (i.e. pad, panty liner, tampon, or menstrual cup containing 5 ml [inclusive] or less of blood). Prolonged bleeding and/or spotting is defined more than 14 continuous days of bleeding and/or spotting, per 90-day reference period (RP).	Up to 24 months
Number of Complications Associated with Implant Removal	Complications associated with implant removal will include failed implant removal; implant site fibrosis; extension of incision of >1 cm; removal of a nonpalpable implant; removal of a deeply placed implant; implant removal in an operating room; implant removal requiring general anesthesia; implant removal requiring regional anesthesia; implant removal requiring imaging guidance; nerve injury during implant removal; vascular injury during implant removal; other complications of device removal not previously mentioned.	Up to 24 months

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Estimated): December 28, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Etonogestrel
• Other Study ID Numbers: 8415-060; 2020-001232-95 (EudraCT Number); MK-8415-060 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes