Trial Outcomes & Findings for Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3) (NCT NCT02354534)

NCT ID: NCT02354534

Last Updated: 2021-04-28

Results Overview

Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 30 participants
• Primary outcome timeframe: 41 weeks
• Results posted on: 2021-04-28

Participant Flow

Participant milestones

Measure	50 mg Artesunate Suppositories, 1 Cycle Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories, 1 Cycle Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,2 Cycles Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,3 Cycles Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
Overall Study STARTED	3	9	10	8
Overall Study COMPLETED	3	9	9	8
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

Baseline characteristics by cohort

Measure	200 mg Artesunate Suppositories,2 Cycles n=10 Participants Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	50 mg Artesunate Suppositories, 1 Cycle n=3 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories, 1 Cycle n=9 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,3 Cycles n=8 Participants Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	3 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	3 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized White	7 Participants n=5 Participants	3 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	10 Participants n=5 Participants	3 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=4 Participants	30 Participants n=21 Participants
Type of HPV at baseline HPV16 only	1 Participants n=5 Participants	0 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Type of HPV at baseline HPV16 and other genotypes	2 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Type of HPV at baseline Non-16 HPV genotypes	7 Participants n=5 Participants	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants

PRIMARY outcome

Timeframe: 41 weeks

Number of participants with serious adverse events or dose limiting toxicities related to the study intervention assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

Outcome measures

Measure	50 mg Artesunate Suppositories, 1 Cycle n=3 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories, 1 Cycle n=9 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,2 Cycles n=10 Participants Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,3 Cycles n=8 Participants Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
Number of Participants With Serious Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 41 weeks

Population: Subjects enrolled in the study who received at least one dose of the investigational drug, and on whom we have outcomes data. 2 participants did not have data collected for this outcome.

Number of participants whose human papillomavirus (HPV) genotypes present at study entry become undetectable without surgical intervention. HPV genotyping detects strains of HPV present at each timepoint. For this outcome, we evaluated whether strains of HPV detected at study entry became undetectable during the study participation.

Outcome measures

Measure	50 mg Artesunate Suppositories, 1 Cycle n=3 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories, 1 Cycle n=9 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,2 Cycles n=8 Participants Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,3 Cycles n=8 Participants Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
Viral Clearance of HPV	1 Participants	3 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 41 weeks

Population: All participants who received at least one dose of the interventional drug and on whom we have outcomes data. 2 participants did not have data collected for this outcome measure.

Number of participants who had histologic regression from cervical intraepithelial neoplasia (CIN) 2/3 to CIN 1 or less, as assessed by colposcopically-directed biopsies. Histologic regression is defined as disappearance of the high grade lesion (CIN2/3) without surgical intervention.

Outcome measures

Measure	50 mg Artesunate Suppositories, 1 Cycle n=3 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories, 1 Cycle n=9 Participants Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,2 Cycles n=8 Participants Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,3 Cycles n=8 Participants Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
Histologic Regression of CIN2/3	2 Participants	7 Participants	5 Participants	5 Participants

Adverse Events

50 mg Artesunate Suppositories, 1 Cycle

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

200 mg Artesunate Suppositories, 1 Cycle

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

200 mg Artesunate Suppositories,2 Cycles

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

200 mg Artesunate Suppositories,3 Cycles

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	50 mg Artesunate Suppositories, 1 Cycle n=3 participants at risk Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories, 1 Cycle n=9 participants at risk Subjects enrolled in this cohort will receive 1 five day cycle of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,2 Cycles n=10 participants at risk Subjects enrolled in this cohort will receive 2 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories	200 mg Artesunate Suppositories,3 Cycles n=8 participants at risk Subjects enrolled in this cohort will receive 3 five day cycles of Artesunate suppositories prior to therapeutic resection of their lesion (if clinically indicated). Artesunate Suppositories
Gastrointestinal disorders Bloating	33.3% 1/3 • Number of events 4 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	11.1% 1/9 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	11.1% 1/9 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Gastrointestinal disorders Diarrhea	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	11.1% 1/9 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Gastrointestinal disorders Nausea	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
General disorders Chills	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
General disorders Fatigue	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
General disorders Fever	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	11.1% 1/9 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
General disorders Flu-like symptoms	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Infections and infestations Vaginal infection	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	22.2% 2/9 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	40.0% 4/10 • Number of events 4 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Infections and infestations Urinary tract infection	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Musculoskeletal and connective tissue disorders Vaginal twitching	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	11.1% 1/9 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	22.2% 2/9 • Number of events 6 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	30.0% 3/10 • Number of events 5 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	37.5% 3/8 • Number of events 3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Nervous system disorders Headache	33.3% 1/3 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	55.6% 5/9 • Number of events 9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	30.0% 3/10 • Number of events 3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	25.0% 2/8 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Psychiatric disorders Anxiety	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Psychiatric disorders Insomnia	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Renal and urinary disorders Cystitis noninfective	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders Uterine cramping	66.7% 2/3 • Number of events 5 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	11.1% 1/9 • Number of events 3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	25.0% 2/8 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders Dyspareunia	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders pelvic pain	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	33.3% 3/9 • Number of events 3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 4 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	37.5% 3/8 • Number of events 4 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders Vaginal dryness	33.3% 1/3 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	11.1% 1/9 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	33.3% 3/9 • Number of events 3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders vaginal inflammation	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 2 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Reproductive system and breast disorders vaginal pain/burning	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	44.4% 4/9 • Number of events 5 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	40.0% 4/10 • Number of events 4 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	50.0% 4/8 • Number of events 7 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Skin and subcutaneous tissue disorders rash	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/10 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	12.5% 1/8 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Skin and subcutaneous tissue disorders pruritus	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/9 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	10.0% 1/10 • Number of events 1 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	0.00% 0/8 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.
Skin and subcutaneous tissue disorders Vaginal pruritus	0.00% 0/3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	33.3% 3/9 • Number of events 3 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	50.0% 5/10 • Number of events 5 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.	75.0% 6/8 • Number of events 11 • 41 weeks All adverse events reported by study participants from the time of study drug administration through 30 days after the final treatment, whether or not they are related to the study intervention. Participants filled out a symptom diary for each treatment cycle completed. Adverse events were also documented and assessed for causality by the study investigators at each study visit.

Additional Information

Cornelia L. Trimble, MD

Johns Hopkins University

Phone: 410-502-0512

Email: CervixDoctor@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place