Trial Outcomes & Findings for Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3) (NCT NCT02864147)
NCT ID: NCT02864147
Last Updated: 2024-05-02
Results Overview
The major parameters of objective response to be assessed include treatment efficacy defined as histologic regression of cervical dysplasia to CIN 1 or less after the end of imiquimod treatment, HPV clearance and treatment tolerance. Objective response will be categorized as 'yes' or 'no' and included in the evaluations are the following criteria: * Histologic regression (HR): Histologic regression of all index lesions to CIN 1 or less after end of imiquimod treatment period. * Histologic remission (HM): Complete regression of cervical dysplasia at all index biopsy sites after end of imiquimod treatment period. * Persistent Disease (PR): One or more index lesions persists with CIN 2,3 high grade dysplasia or new lesions are identified colposcopically and histologically confirmed to be CIN 2,3. * Progressive Disease (PD): Worsening histology of an index lesion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
Between weeks 20 and 24 (approximately week 22)
Results posted on
2024-05-02
Participant Flow
Participant milestones
| Measure |
Observation Only (Control)
Participants randomized to the control group will only be observed and will receive no intervention.
|
Imiquimod Only
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Imiquimod + 9-valent HPV Vaccine
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
9-valent HPV vaccine: All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
43
|
|
Overall Study
Completed Treatment
|
45
|
45
|
43
|
|
Overall Study
Placed On Follow Up
|
29
|
35
|
28
|
|
Overall Study
COMPLETED
|
38
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
5
|
Reasons for withdrawal
| Measure |
Observation Only (Control)
Participants randomized to the control group will only be observed and will receive no intervention.
|
Imiquimod Only
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Imiquimod + 9-valent HPV Vaccine
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
9-valent HPV vaccine: All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
4
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Opted for excisional procedures
|
0
|
0
|
3
|
Baseline Characteristics
Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
Baseline characteristics by cohort
| Measure |
Observation Only (Control)
n=45 Participants
Participants randomized to the control group will only be observed and will receive no intervention.
|
Imiquimod Only
n=45 Participants
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Imiquimod + 9-valent HPV Vaccine
n=43 Participants
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
9-valent HPV vaccine: All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
133 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
43 participants
n=5 Participants
|
133 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Between weeks 20 and 24 (approximately week 22)Population: Complete case analysis.
The major parameters of objective response to be assessed include treatment efficacy defined as histologic regression of cervical dysplasia to CIN 1 or less after the end of imiquimod treatment, HPV clearance and treatment tolerance. Objective response will be categorized as 'yes' or 'no' and included in the evaluations are the following criteria: * Histologic regression (HR): Histologic regression of all index lesions to CIN 1 or less after end of imiquimod treatment period. * Histologic remission (HM): Complete regression of cervical dysplasia at all index biopsy sites after end of imiquimod treatment period. * Persistent Disease (PR): One or more index lesions persists with CIN 2,3 high grade dysplasia or new lesions are identified colposcopically and histologically confirmed to be CIN 2,3. * Progressive Disease (PD): Worsening histology of an index lesion.
Outcome measures
| Measure |
Imiquimod + 9-valent HPV Vaccine
n=38 Participants
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
9-valent HPV vaccine: All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Imiquimod Only
n=38 Participants
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Observation Only (Control)
n=38 Participants
Participants randomized to the control group will only be observed and will receive no intervention.
|
|---|---|---|---|
|
Incidence of Objective Response
Histologic regression (HR)
|
32 Participants
|
36 Participants
|
30 Participants
|
|
Incidence of Objective Response
Histologic remission (HM)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Objective Response
Persistent Disease (PR)
|
6 Participants
|
2 Participants
|
8 Participants
|
|
Incidence of Objective Response
Progressive Disease (PD)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Between weeks 20 and 24 (approximately week 22)Population: Complete case analysis- 2 participants in imiquimod + 9-valent HPV vaccine were not assessed at follow up.
HPV Clearance will be categorized as 'yes' or 'no' and the evaluations are the following criteria: HPV clearance will be measured by both the Roche cobas HPV Test utilized by pathology concomitant with the pap test at final study visit which assesses for presence of 14 high risk HPV types as well as HPV 16/18 genotyping performed by Santin Lab.
Outcome measures
| Measure |
Imiquimod + 9-valent HPV Vaccine
n=36 Participants
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
9-valent HPV vaccine: All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Imiquimod Only
n=38 Participants
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Observation Only (Control)
n=38 Participants
Participants randomized to the control group will only be observed and will receive no intervention.
|
|---|---|---|---|
|
Incidence of HPV Clearance
HPV Negative
|
18 Participants
|
24 Participants
|
19 Participants
|
|
Incidence of HPV Clearance
HPV Positive
|
18 Participants
|
14 Participants
|
19 Participants
|
Adverse Events
Observation Only (Control)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Imiquimod Only
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Imiquimod + 9-valent HPV Vaccine
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Observation Only (Control)
n=45 participants at risk
Participants randomized to the control group will only be observed and will receive no intervention.
|
Imiquimod Only
n=45 participants at risk
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Imiquimod + 9-valent HPV Vaccine
n=43 participants at risk
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
9-valent HPV vaccine: All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
Other adverse events
| Measure |
Observation Only (Control)
n=45 participants at risk
Participants randomized to the control group will only be observed and will receive no intervention.
|
Imiquimod Only
n=45 participants at risk
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
Imiquimod + 9-valent HPV Vaccine
n=43 participants at risk
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
9-valent HPV vaccine: All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Imiquimod: At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45 • Up to 24 weeks
|
4.4%
2/45 • Number of events 2 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 2 • Up to 24 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/45 • Up to 24 weeks
|
8.9%
4/45 • Number of events 4 • Up to 24 weeks
|
7.0%
3/43 • Number of events 4 • Up to 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
General disorders
Chills
|
0.00%
0/45 • Up to 24 weeks
|
6.7%
3/45 • Number of events 3 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
General disorders
Fatigue
|
0.00%
0/45 • Up to 24 weeks
|
17.8%
8/45 • Number of events 8 • Up to 24 weeks
|
16.3%
7/43 • Number of events 7 • Up to 24 weeks
|
|
General disorders
Fever
|
0.00%
0/45 • Up to 24 weeks
|
11.1%
5/45 • Number of events 5 • Up to 24 weeks
|
11.6%
5/43 • Number of events 6 • Up to 24 weeks
|
|
General disorders
Flu like symptoms
|
0.00%
0/45 • Up to 24 weeks
|
46.7%
21/45 • Number of events 24 • Up to 24 weeks
|
41.9%
18/43 • Number of events 20 • Up to 24 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
4.4%
2/45 • Number of events 4 • Up to 24 weeks
|
7.0%
3/43 • Number of events 3 • Up to 24 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
General disorders
Malaise
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
General disorders
Pain
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
2.2%
1/45 • Number of events 2 • Up to 24 weeks
|
4.7%
2/43 • Number of events 2 • Up to 24 weeks
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
6.7%
3/45 • Number of events 3 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/45 • Up to 24 weeks
|
26.7%
12/45 • Number of events 14 • Up to 24 weeks
|
16.3%
7/43 • Number of events 9 • Up to 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
7.0%
3/43 • Number of events 3 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
4.7%
2/43 • Number of events 2 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/45 • Up to 24 weeks
|
6.7%
3/45 • Number of events 3 • Up to 24 weeks
|
9.3%
4/43 • Number of events 4 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Nervous system disorders
Dizziness
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Nervous system disorders
Headache
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
8.9%
4/45 • Number of events 4 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 2 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 3 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 2 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
40.0%
18/45 • Number of events 23 • Up to 24 weeks
|
48.8%
21/43 • Number of events 27 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/45 • Up to 24 weeks
|
8.9%
4/45 • Number of events 4 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/45 • Up to 24 weeks
|
6.7%
3/45 • Number of events 4 • Up to 24 weeks
|
7.0%
3/43 • Number of events 3 • Up to 24 weeks
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/45 • Up to 24 weeks
|
20.0%
9/45 • Number of events 13 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/43 • Up to 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • Up to 24 weeks
|
2.2%
1/45 • Number of events 1 • Up to 24 weeks
|
4.7%
2/43 • Number of events 2 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/45 • Up to 24 weeks
|
6.7%
3/45 • Number of events 4 • Up to 24 weeks
|
2.3%
1/43 • Number of events 2 • Up to 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/45 • Up to 24 weeks
|
0.00%
0/45 • Up to 24 weeks
|
2.3%
1/43 • Number of events 1 • Up to 24 weeks
|
Additional Information
Alessandro Santin, MD
Clinical Research Team Leader, Gynecologic Oncology, Yale Cancer Center
Phone: (203) 200-4176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place