Trial Outcomes & Findings for Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS (NCT NCT03633799)
NCT ID: NCT03633799
Last Updated: 2025-08-22
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
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1620 participants
Primary outcome timeframe
3 years
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
VeraCept
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Overall Study
STARTED
|
1620
|
|
Overall Study
COMPLETED
|
689
|
|
Overall Study
NOT COMPLETED
|
931
|
Reasons for withdrawal
| Measure |
VeraCept
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Overall Study
Adverse Event
|
349
|
|
Overall Study
Withdrawal by Subject
|
288
|
|
Overall Study
Lost to Follow-up
|
97
|
|
Overall Study
Physician Decision
|
9
|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Pregnancy
|
20
|
|
Overall Study
other
|
39
|
|
Overall Study
ongoing within third year of study
|
106
|
|
Overall Study
unsuccessful study drug placement
|
19
|
Baseline Characteristics
Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS
Baseline characteristics by cohort
| Measure |
VeraCept
n=1620 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1620 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
308 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1312 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1196 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Evaluable for pregnancy population
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 |
VeraCept
n=1397 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Contraceptive Efficacy Through 3 Years of Use
|
1.06 Pearl Index
Interval 0.67 to 1.61
|
SECONDARY outcome
Timeframe: Years 4, 5, 6, 7, and 8 and cumulatively through Years 4, 5, 6, 7, and 8Pearl Index will be calculated for Years 4, 5, 6, 7, and 8 as well as cumulatively through Years 4, 5, 6, 7, and 8
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Years 1 through 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 |
VeraCept
n=1397 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Cumulative Pregnancy Percentage
Year 1
|
0.013 Probability
|
|
Cumulative Pregnancy Percentage
Year 2
|
0.024 Probability
|
|
Cumulative Pregnancy Percentage
Year 3
|
0.028 Probability
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1) / VeraCept placementPopulation: Number of subjects in ITT population with available information regarding ease of placement at first attempt.
Ease of VeraCept placement will be summarized for the ITT population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard). (First Attempt)
Outcome measures
| Measure |
VeraCept
n=1609 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Ease of VeraCept Placement
very easy
|
844 Participants
|
|
Ease of VeraCept Placement
easy
|
502 Participants
|
|
Ease of VeraCept Placement
neither easy nor hard
|
160 Participants
|
|
Ease of VeraCept Placement
hard
|
77 Participants
|
|
Ease of VeraCept Placement
very hard
|
26 Participants
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1) / VeraCept placementThe number and percentage of subjects with either a successful or unsuccessful placement will be summarized for the ITT
Outcome measures
| Measure |
VeraCept
n=1620 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
VeraCept Placement Success
successful first attempt of placement
|
1549 Participants
|
|
VeraCept Placement Success
successful second attempt of placement
|
52 Participants
|
|
VeraCept Placement Success
failed placement
|
7 Participants
|
|
VeraCept Placement Success
second attempt not tried
|
12 Participants
|
SECONDARY outcome
Timeframe: Through year 1Population: evaluable for cycle control population
Bleeding and spotting patterns will be summarized for the first year of treatment by the number of days in each 28-day cycle with bleeding or spotting, bleeding only, and spotting only
Outcome measures
| Measure |
VeraCept
n=1587 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Bleeding and Spotting Patterns
cycle 1: bleeding or spotting
|
11.2 days
Standard Deviation 4.93
|
|
Bleeding and Spotting Patterns
cycle 1: bleeding only
|
6.4 days
Standard Deviation 3.44
|
|
Bleeding and Spotting Patterns
cycle 1: spotting only
|
4.8 days
Standard Deviation 3.37
|
|
Bleeding and Spotting Patterns
cycle 2: bleeding or spotting
|
7.8 days
Standard Deviation 3.76
|
|
Bleeding and Spotting Patterns
cycle 2: bleeding only
|
5.1 days
Standard Deviation 2.57
|
|
Bleeding and Spotting Patterns
cycle 2: spotting only
|
2.7 days
Standard Deviation 2.56
|
|
Bleeding and Spotting Patterns
cycle 3: bleeding or spotting
|
7.6 days
Standard Deviation 3.73
|
|
Bleeding and Spotting Patterns
cycle 3: bleeding only
|
5.0 days
Standard Deviation 2.69
|
|
Bleeding and Spotting Patterns
cycle 3: spotting only
|
2.5 days
Standard Deviation 2.43
|
|
Bleeding and Spotting Patterns
cycle 4: bleeding or spotting
|
7.3 days
Standard Deviation 3.77
|
|
Bleeding and Spotting Patterns
cycle 4: bleeding only
|
4.9 days
Standard Deviation 2.66
|
|
Bleeding and Spotting Patterns
cycle 4: spotting only
|
2.4 days
Standard Deviation 2.54
|
|
Bleeding and Spotting Patterns
cycle 5: bleeding or spotting
|
7.2 days
Standard Deviation 3.63
|
|
Bleeding and Spotting Patterns
cycle 5: bleeding only
|
4.8 days
Standard Deviation 2.60
|
|
Bleeding and Spotting Patterns
cycle 5: spotting only
|
2.4 days
Standard Deviation 2.33
|
|
Bleeding and Spotting Patterns
cycle 6: bleeding or spotting
|
7.0 days
Standard Deviation 3.48
|
|
Bleeding and Spotting Patterns
cycle 6: bleeding only
|
4.8 days
Standard Deviation 2.64
|
|
Bleeding and Spotting Patterns
cycle 6: spotting only
|
2.2 days
Standard Deviation 2.27
|
|
Bleeding and Spotting Patterns
cycle 7: bleeding or spotting
|
7.2 days
Standard Deviation 3.79
|
|
Bleeding and Spotting Patterns
cycle 7: bleeding only
|
4.7 days
Standard Deviation 2.73
|
|
Bleeding and Spotting Patterns
cycle 7: spotting only
|
2.4 days
Standard Deviation 2.52
|
|
Bleeding and Spotting Patterns
cycle 8: bleeding or spotting
|
7.0 days
Standard Deviation 3.54
|
|
Bleeding and Spotting Patterns
cycle 8: bleeding only
|
4.7 days
Standard Deviation 2.43
|
|
Bleeding and Spotting Patterns
cycle 8: spotting only
|
2.3 days
Standard Deviation 2.51
|
|
Bleeding and Spotting Patterns
cycle 9: bleeding or spotting
|
6.9 days
Standard Deviation 3.60
|
|
Bleeding and Spotting Patterns
cycle 9: bleeding only
|
4.6 days
Standard Deviation 2.58
|
|
Bleeding and Spotting Patterns
cycle 9: spotting only
|
2.2 days
Standard Deviation 2.36
|
|
Bleeding and Spotting Patterns
cycle 10: bleeding or spotting
|
6.9 days
Standard Deviation 3.40
|
|
Bleeding and Spotting Patterns
cycle 10: bleeding only
|
4.6 days
Standard Deviation 2.44
|
|
Bleeding and Spotting Patterns
cycle 10: spotting only
|
2.3 days
Standard Deviation 2.19
|
|
Bleeding and Spotting Patterns
cycle 11: bleeding or spotting
|
6.8 days
Standard Deviation 3.48
|
|
Bleeding and Spotting Patterns
cycle 11: bleeding only
|
4.5 days
Standard Deviation 2.38
|
|
Bleeding and Spotting Patterns
cycle 11: spotting only
|
2.2 days
Standard Deviation 2.60
|
|
Bleeding and Spotting Patterns
cycle 12: bleeding or spotting
|
6.8 days
Standard Deviation 3.38
|
|
Bleeding and Spotting Patterns
cycle 12: bleeding only
|
4.7 days
Standard Deviation 2.55
|
|
Bleeding and Spotting Patterns
cycle 12: spotting only
|
2.2 days
Standard Deviation 2.24
|
|
Bleeding and Spotting Patterns
cycle 13: bleeding or spotting
|
6.9 days
Standard Deviation 3.50
|
|
Bleeding and Spotting Patterns
cycle 13: bleeding only
|
4.6 days
Standard Deviation 2.50
|
|
Bleeding and Spotting Patterns
cycle 13: spotting only
|
2.2 days
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: Visit 1 (Day 1), immediately after insertionPopulation: Number of subjects in ITT population with available information regarding device placement pain at first attempt.
Insertion pain summarized for subjects at first attempt as reported by the subjects
Outcome measures
| Measure |
VeraCept
n=1600 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Insertion Pain Assessed Immediately After Insertion (First Attempt)
no pain
|
85 Participants
|
|
Insertion Pain Assessed Immediately After Insertion (First Attempt)
some pain
|
363 Participants
|
|
Insertion Pain Assessed Immediately After Insertion (First Attempt)
moderately painful
|
661 Participants
|
|
Insertion Pain Assessed Immediately After Insertion (First Attempt)
painful
|
406 Participants
|
|
Insertion Pain Assessed Immediately After Insertion (First Attempt)
very painful
|
85 Participants
|
SECONDARY outcome
Timeframe: Years 1 through 3Population: safety population
Cumulative VeraCept discontinuation rates will be summarized using Kaplan-Meier methods for the Safety population.
Outcome measures
| Measure |
VeraCept
n=1601 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Cumulative VeraCept Discontinuation Rates
Year 1
|
0.195 Probability
|
|
Cumulative VeraCept Discontinuation Rates
Year 2
|
0.329 Probability
|
|
Cumulative VeraCept Discontinuation Rates
Year 3
|
0.419 Probability
|
SECONDARY outcome
Timeframe: Years 1 through 3Population: safety population
Cumulative VeraCept expulsion rates will be summarized using Kaplan-Meier methods for the Safety population.
Outcome measures
| Measure |
VeraCept
n=1601 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Cumulative VeraCept Expulsion Rates
Year 1
|
0.025 Probability
|
|
Cumulative VeraCept Expulsion Rates
Year 2
|
0.040 Probability
|
|
Cumulative VeraCept Expulsion Rates
Year 3
|
0.051 Probability
|
SECONDARY outcome
Timeframe: Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.Population: Number of subjects requesting VeraCept removal to become pregnant with known fertility outcomes
The number and percentage of subjects with each return to fertility response will be summarized for the Safety population.
Outcome measures
| Measure |
VeraCept
n=51 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Return to Fertility. Only for Subjects Requesting VeraCept Removal to Become Pregnant.
pregnancy occurred
|
37 Participants
|
|
Return to Fertility. Only for Subjects Requesting VeraCept Removal to Become Pregnant.
pregnancy did not occur
|
14 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: safety population
Outcome measures
| Measure |
VeraCept
n=1601 Participants
VeraCept® Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Safety Adverse Events of Special Interest: Pelvic Infection (PID or Endometriosis), Uterine Perforations, and Abdominal Pain
uterine perforation
|
2 participants
|
|
Safety Adverse Events of Special Interest: Pelvic Infection (PID or Endometriosis), Uterine Perforations, and Abdominal Pain
pelvic infection (PID or endometriosis)
|
19 participants
|
|
Safety Adverse Events of Special Interest: Pelvic Infection (PID or Endometriosis), Uterine Perforations, and Abdominal Pain
abdominal pain
|
111 participants
|
Adverse Events
VeraCept
Serious events: 52 serious events
Other events: 1551 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
VeraCept
n=1601 participants at risk；n=1620 participants at risk
VeraCept™ Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Infections and infestations
pyelonephritis
|
0.19%
3/1620 • Number of events 3 • 3 years
|
|
Infections and infestations
cellulitis
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Infections and infestations
pneumonia
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Infections and infestations
sepsis
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Psychiatric disorders
anxiety
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Psychiatric disorders
depression
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Psychiatric disorders
suicidal ideation
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
intentional overdose
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Pregnancy, puerperium and perinatal conditions
ectopic pregnancy
|
0.19%
3/1620 • Number of events 3 • 3 years
|
|
Pregnancy, puerperium and perinatal conditions
ruptured ectopic pregnancy
|
0.12%
2/1620 • Number of events 2 • 3 years
|
|
Infections and infestations
appendicitis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Infections and infestations
bacterial colitis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Infections and infestations
COVID-19
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Infections and infestations
infectious mononucleosis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Infections and infestations
pelvic inflammatory disease
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Infections and infestations
tonsillitis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Infections and infestations
urinary tract infection
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Psychiatric disorders
drug use disorder
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Psychiatric disorders
intentional self-injury
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Psychiatric disorders
psychotic disorder
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Psychiatric disorders
substance use disorder
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Psychiatric disorders
substance-induced psychotic disorder
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Psychiatric disorders
suicide attempt
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
accidental overdose
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
tibia fracture
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
uterine perforation
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
abdominal pain
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
food poisoning
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
gastric stenosis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
pancreatitis acute
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
cholecystitis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
cholelithiasis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Hepatobiliary disorders
hepatitis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Nervous system disorders
hemiparesis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Nervous system disorders
migraine
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Nervous system disorders
seizure
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Nervous system disorders
syncope
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
haemorrhagic ovarian cyst
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Reproductive system and breast disorders
ovarian cyst ruptured
|
0.06%
1/1620 • Number of events 2 • 3 years
|
|
Reproductive system and breast disorders
uterine haemorrhage
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
pituitary tumour benign
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leiomyoma
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
anaemia
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Congenital, familial and genetic disorders
choledochal cyst
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
General disorders
chest pain
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Immune system disorders
anaphylactic reaction
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
diabetic complication
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
hypoclycaemia
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
tenosynovitis
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Product Issues
device breakage
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.06%
1/1620 • Number of events 1 • 3 years
|
|
Vascular disorders
hypertension
|
0.06%
1/1620 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
VeraCept
n=1601 participants at risk；n=1620 participants at risk
VeraCept™ Intrauterine Contraceptive
VeraCept: VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
|
|---|---|
|
Reproductive system and breast disorders
heavy menstrual bleeding
|
77.8%
1246/1601 • Number of events 3117 • 3 years
|
|
Reproductive system and breast disorders
dysmenorrhoea
|
73.2%
1172/1601 • Number of events 2775 • 3 years
|
|
Reproductive system and breast disorders
pelvic discomfort
|
34.5%
552/1601 • Number of events 1161 • 3 years
|
|
Reproductive system and breast disorders
intermenstrual bleeding
|
30.7%
491/1601 • Number of events 864 • 3 years
|
|
Reproductive system and breast disorders
pelvic pain
|
20.2%
324/1601 • Number of events 559 • 3 years
|
|
Reproductive system and breast disorders
dyspareunia
|
8.0%
128/1601 • Number of events 160 • 3 years
|
|
Reproductive system and breast disorders
vaginal discharge
|
5.4%
87/1601 • Number of events 103 • 3 years
|
|
Infections and infestations
urinary tract infection
|
14.7%
235/1601 • Number of events 338 • 3 years
|
|
Infections and infestations
bacterial vaginosis
|
13.7%
219/1601 • Number of events 350 • 3 years
|
|
Infections and infestations
nasopharyngitis
|
12.2%
196/1601 • Number of events 279 • 3 years
|
|
Infections and infestations
vulvovaginal mycotic infection
|
12.0%
192/1601 • Number of events 298 • 3 years
|
|
Infections and infestations
upper respiratory tract infection
|
8.2%
132/1601 • Number of events 184 • 3 years
|
|
Infections and infestations
COVID-19
|
7.7%
124/1601 • Number of events 128 • 3 years
|
|
Injury, poisoning and procedural complications
procedural pain
|
18.2%
292/1601 • Number of events 317 • 3 years
|
|
Injury, poisoning and procedural complications
post procedural haemorrhage
|
16.7%
267/1601 • Number of events 268 • 3 years
|
|
Injury, poisoning and procedural complications
post procedural discomfort
|
6.1%
97/1601 • Number of events 98 • 3 years
|
|
Gastrointestinal disorders
nausea
|
7.7%
123/1601 • Number of events 168 • 3 years
|
|
Nervous system disorders
headache
|
7.3%
117/1601 • Number of events 216 • 3 years
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.3%
101/1601 • Number of events 128 • 3 years
|
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