Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of LevoCept (NCT NCT02882191)
NCT ID: NCT02882191
Last Updated: 2026-04-23
Results Overview
Contraceptive efficacy through 3 years of use, as assessed by the Pearl Index. The Pearl Index is calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. On-treatment pregnancy is defined as the estimated conception date being on or after the insertion date (must be a successful insertion) and no more than 7 days after the study drug is removed or expelled. One women year is defined as comprising thirteen 28-day cycles. A lower Pearl Index indicates greater contraceptive effectiveness.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
279 participants
Primary outcome timeframe
1 Year, 2 Years, and 3 Years
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
LevoCept IUD
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Overall Study
STARTED
|
279
|
|
Overall Study
COMPLETED
|
154
|
|
Overall Study
NOT COMPLETED
|
125
|
Reasons for withdrawal
| Measure |
LevoCept IUD
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Overall Study
Adverse Event
|
50
|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
40
|
|
Overall Study
Physician Decision
|
6
|
|
Overall Study
Insertion Failure
|
2
|
|
Overall Study
moved from site (2), no longer interested in study (2), self-removed (2), unknown (1)
|
7
|
Baseline Characteristics
Evaluation of the Efficacy and Safety of LevoCept
Baseline characteristics by cohort
| Measure |
LevoCept IUD
n=279 Participants
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 5.16 • n=60 Participants
|
|
Sex: Female, Male
Female
|
279 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
57 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 1 Year, 2 Years, and 3 YearsPopulation: All Evaluable for Pregnancy Subjects
Contraceptive efficacy through 3 years of use, as assessed by the Pearl Index. The Pearl Index is calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. On-treatment pregnancy is defined as the estimated conception date being on or after the insertion date (must be a successful insertion) and no more than 7 days after the study drug is removed or expelled. One women year is defined as comprising thirteen 28-day cycles. A lower Pearl Index indicates greater contraceptive effectiveness.
Outcome measures
| Measure |
LevoCept IUD
n=249 Participants
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Contraceptive Efficacy Through During LevoCept Use
1 Year
|
0 Pregnancies per 100 woman-years
Interval to 1.88
Because no pregnancies occurred, the lower confidence interval cannot be estimated and is therefore reported as NA. This is the expected statistical result when zero events are observed.
|
|
Contraceptive Efficacy Through During LevoCept Use
Cumulative 2 Year
|
0 Pregnancies per 100 woman-years
Interval to 1.11
Because no pregnancies occurred, the lower confidence interval cannot be estimated and is therefore reported as NA. This is the expected statistical result when zero events are observed.
|
|
Contraceptive Efficacy Through During LevoCept Use
Cumulative 3 Year
|
0 Pregnancies per 100 woman-years
Interval to 0.83
Because no pregnancies occurred, the lower confidence interval cannot be estimated and is therefore reported as NA. This is the expected statistical result when zero events are observed.
|
PRIMARY outcome
Timeframe: Years 1-3Population: evaluable for pregnancy population
A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage
Outcome measures
| Measure |
LevoCept IUD
n=249 Participants
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Cumulative Pregnancy Percentage
Year 1
|
0 Percentage probability
|
|
Cumulative Pregnancy Percentage
Year 2
|
0 Percentage probability
|
|
Cumulative Pregnancy Percentage
Year 3
|
0 Percentage probability
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)/ LevoCept PlacementPopulation: Intent to Treat Population
The number and percentage of subjects with either a successful or unsuccessful placement will be summarized
Outcome measures
| Measure |
LevoCept IUD
n=279 Participants
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
LevoCept Placement Success
Successfully Placed at First Attempt
|
260 Participants
|
|
LevoCept Placement Success
Successfully Placed at Second Attempt
|
17 Participants
|
|
LevoCept Placement Success
Not Successfully Placed
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)/ LevoCept PlacementPopulation: Intent to Treat Population
Ease of placement of the LevoCept was assessed by the clinician immediately following device placement. The clinician rated the ease of placement using the following options: "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard." This rating was based on the clinician's experience during the placement procedure.
Outcome measures
| Measure |
LevoCept IUD
n=278 Participants
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Ease of LevoCept Placement
Very Easy
|
137 Participants
|
|
Ease of LevoCept Placement
Easy
|
110 Participants
|
|
Ease of LevoCept Placement
Neither Easy Nor Hard
|
22 Participants
|
|
Ease of LevoCept Placement
Hard
|
8 Participants
|
|
Ease of LevoCept Placement
Very Hard
|
1 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days.Population: Safety Subjects - Enrolled subjects who had a successful device placement. The number of participants reported for each cycle reflects the number of safety subjects who submitted bleeding-related diary data during that specific cycle.
Bleeding and spotting patterns will be summarized for the first year of treatment (Cycle 1 to Cycle 13) by the mean number of days in each 28-day cycle with bleeding or spotting and spotting only
Outcome measures
| Measure |
LevoCept IUD
n=277 Participants
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 2 - Spotting
|
6.4 Days
Standard Deviation 5.03
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 3 - Bleeding or Spotting
|
9.2 Days
Standard Deviation 6.08
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 5 - Spotting
|
3.5 Days
Standard Deviation 3.22
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 6 - Spotting
|
3.5 Days
Standard Deviation 3.74
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 7 - Bleeding or Spotting
|
6.2 Days
Standard Deviation 5.25
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 7 - Spotting
|
3.1 Days
Standard Deviation 3.23
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 8 - Bleeding or Spotting
|
5.7 Days
Standard Deviation 4.89
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 8 - Spotting
|
3.1 Days
Standard Deviation 3.24
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 9 - Bleeding or Spotting
|
5.5 Days
Standard Deviation 4.92
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 9 - Spotting
|
2.9 Days
Standard Deviation 2.9
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 10 - Bleeding or Spotting
|
5.1 Days
Standard Deviation 4.69
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 10 - Spotting
|
2.8 Days
Standard Deviation 3.3
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 11 - Spotting
|
2.6 Days
Standard Deviation 3.11
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 12 - Bleeding or Spotting
|
4.8 Days
Standard Deviation 4.55
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 12 - Spotting
|
2.4 Days
Standard Deviation 2.75
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 13 - Bleeding or Spotting
|
5.1 Days
Standard Deviation 5.09
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 13 - Spotting
|
2.9 Days
Standard Deviation 3.62
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 3 - Spotting
|
4.8 Days
Standard Deviation 4.16
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 4 - Bleeding or Spotting
|
7.6 Days
Standard Deviation 5.62
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 4 - Spotting
|
4.1 Days
Standard Deviation 3.43
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 5 - Bleeding or Spotting
|
6.7 Days
Standard Deviation 5.43
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 6 - Bleeding or Spotting
|
6.4 Days
Standard Deviation 5.17
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 11 - Bleeding or Spotting
|
5.0 Days
Standard Deviation 4.67
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 1 - Bleeding or Spotting
|
13.5 Days
Standard Deviation 7.41
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 1 - Spotting
|
6.6 Days
Standard Deviation 4.93
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 2 - Bleeding or Spotting
|
12.0 Days
Standard Deviation 7.4
|
Adverse Events
LevoCept IUD
Serious events: 4 serious events
Other events: 264 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LevoCept IUD
n=279 participants at risk
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Injury, poisoning and procedural complications
intentional overdose
|
0.36%
1/279 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
renal failure acute
|
0.36%
1/279 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
intussusception
|
0.36%
1/279 • Number of events 1 • 36 Months
|
|
Injury, poisoning and procedural complications
overdose
|
0.36%
1/279 • Number of events 1 • 36 Months
|
Other adverse events
| Measure |
LevoCept IUD
n=279 participants at risk
LevoCept IUD placement
LevoCept: placement of LevoCept IUD
|
|---|---|
|
Reproductive system and breast disorders
dysmenorrhoea
|
52.7%
147/279 • Number of events 297 • 36 Months
|
|
Reproductive system and breast disorders
menorrhagia
|
39.8%
111/279 • Number of events 189 • 36 Months
|
|
Reproductive system and breast disorders
dyspareunia
|
38.4%
107/279 • Number of events 194 • 36 Months
|
|
Reproductive system and breast disorders
metrorrhagia
|
31.2%
87/279 • Number of events 147 • 36 Months
|
|
Reproductive system and breast disorders
pelvic discomfort
|
20.1%
56/279 • Number of events 80 • 36 Months
|
|
Reproductive system and breast disorders
pelvic pain
|
14.7%
41/279 • Number of events 56 • 36 Months
|
|
Reproductive system and breast disorders
uterine spasm
|
10.4%
29/279 • Number of events 37 • 36 Months
|
|
Infections and infestations
upper respiratory tract infection
|
14.0%
39/279 • Number of events 84 • 36 Months
|
|
Infections and infestations
nasopharyngitis
|
12.9%
36/279 • Number of events 64 • 36 Months
|
|
Infections and infestations
bacterial vaginosis
|
11.5%
32/279 • Number of events 42 • 36 Months
|
|
Infections and infestations
influenza
|
8.2%
23/279 • Number of events 25 • 36 Months
|
|
Infections and infestations
urinary tract infection
|
7.2%
20/279 • Number of events 26 • 36 Months
|
|
Infections and infestations
vulvovaginal mycotic infection
|
6.5%
18/279 • Number of events 21 • 36 Months
|
|
Injury, poisoning and procedural complications
post-procedure discomfort
|
12.5%
35/279 • Number of events 35 • 36 Months
|
|
Injury, poisoning and procedural complications
post-procedure haemorrhage
|
8.2%
23/279 • Number of events 24 • 36 Months
|
|
Injury, poisoning and procedural complications
procedural pain
|
6.1%
17/279 • Number of events 20 • 36 Months
|
|
Gastrointestinal disorders
abdominal pain
|
5.7%
16/279 • Number of events 24 • 36 Months
|
|
Skin and subcutaneous tissue disorders
acne
|
6.5%
18/279 • Number of events 18 • 36 Months
|
|
Nervous system disorders
headache
|
5.0%
14/279 • Number of events 14 • 36 Months
|
Additional Information
Elizabeth Gray, Manager, Clinical Operations
Sebela Women's Health
Phone: 760-593-8383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place