A Study to Assess Contraceptive Efficacy and Safety of Et... | NCT04626596

ID	Type	Description	Link
2020-001232-95	EudraCT Number
MK-8415-060	Other Identifier	Merck

Status Module

Label	Type	Description	Intervention Names
ENG implant	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
Radiopaque Etonogestrel (ENG) Implant	Combination Product	68 mg subdermal implant	ENG implant

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Clinical Therapeutics (Site 0222)		Birmingham	Alabama	35205	United States
Desert Star Family Planning (Site 0193)

ID	Term
D000071063	Endoglin
D004343	Drug Implants
C044815	etonogestrel

ID	Term
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D003692	Delayed-Action Preparations
D004304	Dosage Forms
D004364	Pharmaceutical Preparations