Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Radiopaque Etonogestrel (ENG) Implant, Radiopaque Etonogestrel Implant
Radiopaque Etonogestrel · 2 trials · 1 indication
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.
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.
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.
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.
In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator \& the implant. The percentage of AUs who were very satisfied and satisfied was presented.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented.
The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.
The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Radiopaque Etonogestrel Implant | EXPERIMENTAL | Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Applicator (NGA) The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray. The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year. |
| Name | Type | Description |
|---|---|---|
| Radiopaque Etonogestrel (ENG) Implant | COMBINATION_PRODUCT | 68 mg subdermal implant |
| Radiopaque Etonogestrel Implant | DRUG | One implant inserted for a 3-year treatment period |
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 in...
Radiopaque Etonogestrel is an investigational small-molecule contraceptive implant developed by Organon & Co. (ticker OGN). It is a radiopaque version of the etonogestrel implant, meaning it can be detected by imaging. It is being studied for contraception and is in Phase 3 clinical development.
Radiopaque Etonogestrel is being developed for contraception in women. Its clinical program has evaluated contraceptive efficacy and safety of the etonogestrel implant beyond three years of use, as well as insertion characteristics using a next generation applicator. It is not yet approved and remains in Phase 3 development.
Radiopaque Etonogestrel is developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor of the clinical trials evaluating the radiopaque etonogestrel implant for contraception.
Radiopaque Etonogestrel is in Phase 3 clinical development. Two Phase 3 trials have been completed, and no trials are currently active. The program has enrolled a total of 799 participants across those completed studies. The drug is investigational and has not been approved.
Two completed Phase 3 trials have studied Radiopaque Etonogestrel. NCT04626596 assessed contraceptive efficacy and safety of the etonogestrel implant beyond three years of use, enrolling 498 participants in the United States and Puerto Rico. NCT00620035 evaluated insertion characteristics of the radiopaque etonogestrel implant using a next generation applicator, enrolling 301 women aged 18 years and older.
Yes. Radiopaque Etonogestrel is also known as the Radiopaque Etonogestrel (ENG) Implant and the Radiopaque Etonogestrel Implant. These names refer to the same Organon & Co. contraceptive implant in Phase 3 development.