Trial Outcomes & Findings for Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception (NCT NCT02446821)
NCT ID: NCT02446821
Last Updated: 2025-08-22
Results Overview
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
286 participants
Primary outcome timeframe
12 months
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
VeraCept IUD System
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
Overall Study
STARTED
|
286
|
|
Overall Study
COMPLETED
|
218
|
|
Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
| Measure |
VeraCept IUD System
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
Overall Study
Adverse Event
|
28
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
other
|
9
|
|
Overall Study
insertion failure
|
3
|
Baseline Characteristics
Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception
Baseline characteristics by cohort
| Measure |
VeraCept IUD System
n=286 Participants
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 5.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
286 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
238 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
182 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Evaluation for Pregnancy Population
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 |
VeraCept IUD System
n=248 Participants
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index
All evaluable for pregnancy subjects
|
0.53 Pearl Index
Interval 0.01 to 2.93
|
|
The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index
evaluable for pregnancy subjects with at least one live birth
|
1.41 Pearl Index
Interval 0.04 to 7.88
|
|
The Primary Outcome Measure is Effectiveness as Calculated by the Pearl Index
evaluable for pregnancy subjects never had live birth
|
0.00 Pearl Index
Interval 0.0 to 3.08
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)/ VeraCept PlacementPopulation: Intent to Treat Population
The number and percentage of subjects with either a successful or unsuccessful placement will be summarized
Outcome measures
| Measure |
VeraCept IUD System
n=286 Participants
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
VeraCept Placement Success
successfully placed on first attempt
|
267 Participants
|
|
VeraCept Placement Success
successfully placed on second attempt
|
18 Participants
|
|
VeraCept Placement Success
not successfully placed
|
3 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1)/ VeraCept PlacementPopulation: Safety Population
Ease of placement of the VeraCept 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 |
VeraCept IUD System
n=283 Participants
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
Ease of VeraCept Placement
Very Easy
|
173 Participants
|
|
Ease of VeraCept Placement
Easy
|
86 Participants
|
|
Ease of VeraCept Placement
Neither Easy nor Hard
|
11 Participants
|
|
Ease of VeraCept Placement
Hard
|
8 Participants
|
|
Ease of VeraCept Placement
Very Hard
|
5 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 to Cycle 13 (post IUD placement). Each cycle is 28 days.Population: The Evaluable for Cycle Control (ECYC) Population includes subjects who provided bleeding-related diary data. The number of participants reported for each cycle reflects the number of ECYC 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, bleeding only, and spotting only
Outcome measures
| Measure |
VeraCept IUD System
n=275 Participants
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 1 : bleeding or spotting
|
11.2 Days
Standard Deviation 5.83
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 1 : bleeding only
|
7.6 Days
Standard Deviation 4.35
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 1 : spotting only
|
3.6 Days
Standard Deviation 3.71
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 2 : bleeding or spotting
|
8.1 Days
Standard Deviation 4.22
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 2 : bleeding only
|
5.8 Days
Standard Deviation 3.29
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 2 : spotting only
|
2.2 Days
Standard Deviation 2.61
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 3 : bleeding or spotting
|
7.8 Days
Standard Deviation 4.12
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 3 : bleeding only
|
5.8 Days
Standard Deviation 3.02
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 3 : spotting only
|
2.0 Days
Standard Deviation 2.32
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 4 : bleeding or spotting
|
7.2 Days
Standard Deviation 3.62
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 4 : bleeding only
|
5.3 Days
Standard Deviation 2.60
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 4 : spotting only
|
1.9 Days
Standard Deviation 2.38
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 5 : bleeding or spotting
|
7.0 Days
Standard Deviation 3.67
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 5 : bleeding only
|
5.3 Days
Standard Deviation 2.70
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 5 : spotting only
|
1.8 Days
Standard Deviation 2.61
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 6 : bleeding or spotting
|
7.6 Days
Standard Deviation 4.60
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 6 : bleeding only
|
5.6 Days
Standard Deviation 3.60
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 6 : spotting only
|
2.0 Days
Standard Deviation 2.76
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 7 : bleeding or spotting
|
7.1 Days
Standard Deviation 3.81
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 7 : bleeding only
|
5.3 Days
Standard Deviation 2.89
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 7 : spotting only
|
1.8 Days
Standard Deviation 2.25
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 8 : bleeding or spotting
|
6.9 Days
Standard Deviation 3.83
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 8 : bleeding only
|
5.3 Days
Standard Deviation 2.94
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 8 : spotting only
|
1.6 Days
Standard Deviation 2.03
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 9 : bleeding or spotting
|
7.1 Days
Standard Deviation 4.00
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 9 : bleeding only
|
5.3 Days
Standard Deviation 2.84
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 9 : spotting only
|
1.7 Days
Standard Deviation 2.39
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 10 : bleeding or spotting
|
7.0 Days
Standard Deviation 3.75
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 10 : bleeding only
|
5.2 Days
Standard Deviation 2.90
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 10 : spotting only
|
1.7 Days
Standard Deviation 2.37
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 11 : bleeding or spotting
|
7.0 Days
Standard Deviation 3.57
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 11 : bleeding only
|
5.3 Days
Standard Deviation 2.35
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 11 : spotting only
|
1.7 Days
Standard Deviation 2.40
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 12 : bleeding or spotting
|
7.0 Days
Standard Deviation 4.25
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 12 : bleeding only
|
5.4 Days
Standard Deviation 3.25
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 12 : spotting only
|
1.7 Days
Standard Deviation 2.35
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 13 : bleeding or spotting
|
7.1 Days
Standard Deviation 4.75
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 13 : bleeding only
|
5.2 Days
Standard Deviation 3.56
|
|
Bleeding and Spotting Patterns (Number of Bleeding and/or Spotting Days Per Cycle)
Cycle 13 : spotting only
|
1.9 Days
Standard Deviation 2.96
|
Adverse Events
VeraCept IUD System
Serious events: 4 serious events
Other events: 243 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VeraCept IUD System
n=283 participants at risk；n=286 participants at risk
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
Infections and infestations
chronic tonsillitis
|
0.35%
1/286 • Number of events 1 • 12 months
|
|
Infections and infestations
cellulitis
|
0.35%
1/286 • Number of events 1 • 12 months
|
|
Blood and lymphatic system disorders
hyperbilirubinaemia
|
0.35%
1/286 • Number of events 1 • 12 months
|
|
Infections and infestations
urinary tract infection
|
0.35%
1/286 • Number of events 1 • 12 months
|
|
Infections and infestations
pelvic inflammatory disease
|
0.35%
1/286 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
VeraCept IUD System
n=283 participants at risk；n=286 participants at risk
All women will receive VeraCept.
VeraCept: IUD placement of VeraCept
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
13.4%
38/283 • Number of events 66 • 12 months
|
|
Gastrointestinal disorders
abdominal pain lower
|
7.4%
21/283 • Number of events 43 • 12 months
|
|
Gastrointestinal disorders
nausea
|
5.3%
15/283 • Number of events 15 • 12 months
|
|
Infections and infestations
bacterial vaginosis
|
11.7%
33/283 • Number of events 43 • 12 months
|
|
Infections and infestations
nasopharyngitis
|
21.6%
61/283 • Number of events 84 • 12 months
|
|
Infections and infestations
upper respirtory tract infection
|
12.7%
36/283 • Number of events 51 • 12 months
|
|
Infections and infestations
urinary tract infection
|
11.0%
31/283 • Number of events 35 • 12 months
|
|
Infections and infestations
vulvovaginal mycotic infection
|
9.2%
26/283 • Number of events 31 • 12 months
|
|
Injury, poisoning and procedural complications
post procedural haemorrhage
|
7.4%
21/283 • Number of events 21 • 12 months
|
|
Injury, poisoning and procedural complications
procedural pain
|
35.0%
99/283 • Number of events 130 • 12 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
10.6%
30/283 • Number of events 52 • 12 months
|
|
Nervous system disorders
headache
|
13.8%
39/283 • Number of events 97 • 12 months
|
|
Reproductive system and breast disorders
dysmenorrhoea
|
42.4%
120/283 • Number of events 234 • 12 months
|
|
Reproductive system and breast disorders
dyspareunia
|
7.8%
22/283 • Number of events 24 • 12 months
|
|
Reproductive system and breast disorders
menorrhagia
|
26.1%
74/283 • Number of events 177 • 12 months
|
|
Reproductive system and breast disorders
metrorrhagia
|
12.4%
35/283 • Number of events 49 • 12 months
|
|
Reproductive system and breast disorders
pelvic pain
|
12.4%
35/283 • Number of events 64 • 12 months
|
|
Reproductive system and breast disorders
uterine spasm
|
8.5%
24/283 • Number of events 25 • 12 months
|
|
Reproductive system and breast disorders
vaginal discharge
|
6.4%
18/283 • Number of events 20 • 12 months
|
Additional Information
Elizabeth Gray, Manager, Clinical Operations
Sebela Women's Health Inc.
Phone: 760-593-8383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place