Trial Outcomes & Findings for A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702) (NCT NCT00620035)
NCT ID: NCT00620035
Last Updated: 2022-02-04
Results Overview
In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
301 participants
Primary outcome timeframe
Day 1
Results posted on
2022-02-04
Participant Flow
At screening, a participant number was allocated to 308 participants of which 7 participants did not receive treatment. A total of 301 participants had an implant inserted.
Participant milestones
| Measure |
Radiopaque Etonogestrel Implant
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
|
|---|---|
|
Overall Study
STARTED
|
301
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
145
|
Reasons for withdrawal
| Measure |
Radiopaque Etonogestrel Implant
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
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|---|---|
|
Overall Study
Adverse Event
|
106
|
|
Overall Study
Withdrawal of Informed Consent
|
1
|
|
Overall Study
Other Reason
|
38
|
Baseline Characteristics
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
Baseline characteristics by cohort
| Measure |
Radiopaque Etonogestrel Implant
n=301 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
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|---|---|
|
Age, Customized
18-20 years
|
43 participants
n=5 Participants
|
|
Age, Customized
21-25 years
|
79 participants
n=5 Participants
|
|
Age, Customized
26-30 years
|
64 participants
n=5 Participants
|
|
Age, Customized
31-35 years
|
54 participants
n=5 Participants
|
|
Age, Customized
36-40 years
|
61 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
301 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.
In order to evaluate efficacy and ease of use of the Next Generation Applicator (NGA), the investigator/applicator user (AU) completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Design/technical aspects' consisted of five questions: fit of the applicator in the hand, size, weight, handling, and color of the applicator were assessed. The percentage of AUs who were very satisfied and satisfied was presented.
Outcome measures
| Measure |
Radiopaque Etonogestrel Implant
n=23 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
|
|---|---|
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Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Design & Technical Aspects
|
99.1 Percentage of Applicator Users
|
PRIMARY outcome
Timeframe: Day 1Population: The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Functionality' consisted of six questions assessing functionality of the needle. The percentage of AUs who were very satisfied and satisfied was presented.
Outcome measures
| Measure |
Radiopaque Etonogestrel Implant
n=23 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
|
|---|---|
|
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Functionality
|
94.9 Percentage of Applicator Users
|
PRIMARY outcome
Timeframe: Day 1Population: The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Safety' consisted of three questions: removal of the protection cap from applicator, full retraction of the needle into the applicator after insertion, difference in colors of the obturator \& the implant. The percentage of AUs who were very satisfied and satisfied was presented.
Outcome measures
| Measure |
Radiopaque Etonogestrel Implant
n=23 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
|
|---|---|
|
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire by Domain: Safety
|
98.6 Percentage of Applicator Users
|
PRIMARY outcome
Timeframe: Day 1Population: The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Used Time' consisted of one question: insertion time was assessed. The percentage of AUs who were very satisfied and satisfied was presented.
Outcome measures
| Measure |
Radiopaque Etonogestrel Implant
n=23 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
|
|---|---|
|
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Used Time
|
100 Percentage of Applicator Users
|
PRIMARY outcome
Timeframe: Day 1Population: The Applicator User (AU) group consisted of all investigators participating in the trial and who performed at least one insertion.
In order to evaluate efficacy and ease of use of the NGA, the investigator/AU completed a User Satisfaction Questionnaire on Day 1 after the 12th implant insertion. The domain, 'Applicator Satisfaction' consisted of one question in order to assess the applicator. The percentage of AUs who were very satisfied and satisfied was presented.
Outcome measures
| Measure |
Radiopaque Etonogestrel Implant
n=23 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
|
|---|---|
|
Percentage of Applicator Users Who Were Very Satisfied and Satisfied- User Satisfaction Questionnaire for Domain: Applicator Satisfaction
|
100 Percentage of Applicator Users
|
PRIMARY outcome
Timeframe: Day 1Population: All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 291 implant insertions.
The implant insertion time was the time expressed in seconds, from removal of the protection cap from the applicator until retraction of the needle from the arm after insertion. Data was presented for overall investigators including experienced and non-experienced.
Outcome measures
| Measure |
Radiopaque Etonogestrel Implant
n=291 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
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|---|---|
|
Implant Insertion Time (Seconds)
|
27.9 Seconds
Standard Deviation 29.3
|
PRIMARY outcome
Timeframe: Day 1Population: All-Subjects-Treated (AST) group included all participants who had the Radiopaque implant inserted (N=301). Data was reported for 292 implant removals.
The implant removal time was the time expressed in seconds, from making the removal incision until placing the butterfly closure. Data was presented for overall investigators including experienced and non-experienced.
Outcome measures
| Measure |
Radiopaque Etonogestrel Implant
n=292 Participants
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
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|---|---|
|
Implant Removal Time (Seconds)
|
119.3 Seconds
Standard Deviation 120.2
|
Adverse Events
Radiopaque Etonogestrel Implant
Serious events: 17 serious events
Other events: 233 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiopaque Etonogestrel Implant
n=301 participants at risk
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
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|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Hepatobiliary disorders
Jaundice
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Appendicitis
|
0.66%
2/301 • Number of events 2 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Cancer
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Nervous system disorders
Lethargy
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Nervous system disorders
Migraine
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Nervous system disorders
Sciatica
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Psychiatric disorders
Bipolar Disorder
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Psychiatric disorders
Depression
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Psychiatric disorders
Suicide Attempt
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.33%
1/301 • Number of events 1 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
Other adverse events
| Measure |
Radiopaque Etonogestrel Implant
n=301 participants at risk
The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.
The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
|
|---|---|
|
General disorders
Implant Site Haematoma
|
5.3%
16/301 • Number of events 16 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
General disorders
Implant Site Pain
|
6.0%
18/301 • Number of events 20 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Influenza
|
6.3%
19/301 • Number of events 22 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Nasopharyngitis
|
10.6%
32/301 • Number of events 45 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.6%
20/301 • Number of events 30 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Urinary Tract Infection
|
6.6%
20/301 • Number of events 31 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
6.3%
19/301 • Number of events 26 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Investigations
Weight Increased
|
11.6%
35/301 • Number of events 38 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Nervous system disorders
Headache
|
18.6%
56/301 • Number of events 103 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
7.0%
21/301 • Number of events 23 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.3%
16/301 • Number of events 18 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Reproductive system and breast disorders
Menorrhagia
|
10.3%
31/301 • Number of events 35 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
17.6%
53/301 • Number of events 60 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
28.2%
85/301 • Number of events 126 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
|
Reproductive system and breast disorders
Acne
|
13.0%
39/301 • Number of events 48 • Safety data from the actual in-treatment period was used. The in-treatment period started on the day of the implant insertion and continued up to and including the fifth day after implant removal (3 years).
The safety analysis was performed for the AST group; all subjects who had the Radiopaque Implant inserted.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee SPONSOR recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by SPONSOR. Any such scientific paper, presentation, or other communication concerning the clinical trial described in protocol will first be submitted to SPONSOR, at least six weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER