Trial Outcomes & Findings for Ovarian Function With ENG Implant and UPA Use (NCT NCT04291001)

NCT ID: NCT04291001

Last Updated: 2024-07-12

Results Overview

Ovulation will be monitored by ultrasound and serum LH and progesterone levels

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2024-07-12

Participant Flow

Participant milestones

Measure	ENG Implant Alone Women will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device	ENG Implant Plus Oral UPA Women will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ovarian Function With ENG Implant and UPA Use

Baseline characteristics by cohort

Measure	ENG Implant Alone n=20 Participants Women will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device	ENG Implant Plus Oral UPA n=20 Participants Women will receive a contraceptive implant and oral UPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive	Total n=40 Participants Total of all reporting groups
Age, Continuous	23.2 years STANDARD_DEVIATION 3.9 • n=5 Participants	24.3 years STANDARD_DEVIATION 3.5 • n=7 Participants	23.7 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
BMI	24.2 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants	23.7 kg/m^2 STANDARD_DEVIATION 3.1 • n=7 Participants	24.0 kg/m^2 STANDARD_DEVIATION 2.9 • n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: Outcome Measure was pre-specified to assess "ENG Implant Alone"

Ovulation will be monitored by ultrasound and serum LH and progesterone levels

Outcome measures

Measure	ENG Implant Alone n=20 Participants Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device	ENG Implant Plus Oral UPA ParticipantsUPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
Number of Participants With Ovulation With Implant-alone	7 Participants	0 Participants

PRIMARY outcome

Timeframe: 5 days

Population: Outcome Measure was pre-specified to assess "ENG Implant plus oral UPA"

Ovulation will be monitored by ultrasound and serum LH and progesterone levels

Outcome measures

Measure	ENG Implant Alone Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device	ENG Implant Plus Oral UPA n=19 Participants ParticipantsUPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
Number of Participants With Ovulation With Implant and Same Day UPA	0 Participants	13 Participants

Adverse Events

ENG Implant Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ENG Implant Plus Oral UPA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ENG Implant Alone n=20 participants at risk Participants will receive a contraceptive implant in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device	ENG Implant Plus Oral UPA n=20 participants at risk ParticipantsUPA the same day in the setting of a dominant follicle to assess ovulation incidence and timing following insertion. ENG implant: This is an FDA-approved contraceptive device oral ulipristal acetate: This is an FDA-approved oral emergency contraceptive
Musculoskeletal and connective tissue disorders Pain	0.00% 0/20 • 30 days after final study visit, up to 44 days	5.0% 1/20 • Number of events 1 • 30 days after final study visit, up to 44 days

Additional Information

Lori Gawron, MD

University of Utah

Phone: 801-213-4989

Email: lori.gawron@hsc.utah.edu

Results disclosure agreements

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