Trial Outcomes & Findings for Shoulder Contraceptive Implant Study (NCT NCT04463693)

NCT ID: NCT04463693

Last Updated: 2023-06-08

Results Overview

Serum etonogestrel concentration curves measured over the first year of implant use

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: 1 week and 12 months
• Results posted on: 2023-06-08

Participant Flow

Participant milestones

Measure	Etonogestrel Implant Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Shoulder Contraceptive Implant Study

Baseline characteristics by cohort

Measure	Etonogestrel Implant n=5 Participants Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
Age, Continuous	26.0 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Body mass index	25.0 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 1 week and 12 months

Serum etonogestrel concentration curves measured over the first year of implant use

Outcome measures

Measure	Etonogestrel Implant n=5 Participants Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
Pharmacokinetics in the Form of Serum Etonogestrel Concentrations One-week post insertion	511.7 pg/mL Standard Deviation 168.2
Pharmacokinetics in the Form of Serum Etonogestrel Concentrations 12 months post-insertion	136.6 pg/mL Standard Deviation 21.8

SECONDARY outcome

Timeframe: One and two weeks for "post-insertion site discomfort", over 12 months for "Amenorrhea", "Persistent bleeding", and "Intermittent bleeding"

Local and systematic side effects associated with etonogestrel contraceptive implant use

Outcome measures

Measure	Etonogestrel Implant n=5 Participants Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
Number of Participants With Side Effects Amenorrhea	1 Participants
Number of Participants With Side Effects One-week post insertion site discomfort	4 Participants
Number of Participants With Side Effects Two-week post insertion site discomfort	0 Participants
Number of Participants With Side Effects Persistent bothersome bleeding	1 Participants
Number of Participants With Side Effects Intermittent bleeding	3 Participants

Adverse Events

Etonogestrel Implant

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Etonogestrel Implant n=5 participants at risk Insertion of the etonogestrel contraceptive implant subdermally over the non-dominant scapula Etonogestrel implant: Insertion of the contraceptive implant at an alternative insertion site located over the scapula
Skin and subcutaneous tissue disorders One week post-insertion site discomfort	80.0% 4/5 • 12 months
Reproductive system and breast disorders Persistent bothersome uterine bleeding	20.0% 1/5 • 12 months
Reproductive system and breast disorders Intermittent uterine bleeding	60.0% 3/5 • 12 months

Additional Information

Aaron Lazorwitz

University of Colorado Anschutz Medical Campus

Phone: 3037242019

Email: aaron.lazorwitz@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place