Trial Outcomes & Findings for Dose-finding Study of Moxidectin for Treatment of Scabies (NCT NCT03905265)

Last Updated: 2023-09-22

Results Overview

Adult scabies mite death was based on the reflectance confocal microscopy (RCM) morphology assessment of 2 live adult scabies mites nominated pre-treatment (Baseline), hence overall number of units analyzed are different from the overall number of participants. For the outcome measure, the number of adult mites assessed at each timepoint is the sum of the number of adult mites from all participants in the analysis population for each dose. Therefore, mortality was assessed in 2 mites in the 2 mg group, 6 in the 8 mg group, 8 in the 20 mg group and 14 in the 32 mg group. Adult mite death was defined as the degradation (homogenization of internal structures and/or external anatomic structures, and increased reflectance) of the adult mite observed by RCM. The number of dead mites was assessed at Hours 4, 8, 24, 48 and 72, and Days 7, 14 and 28 compared to the baseline adult mites.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

28 days

Results posted on

2023-09-22

Participant Flow

The study was open to recruitment on 13 Jan 2020 and the First participant was screened on 15 Jan 2020. Last participant last study visit was completed on 28 Feb 2022.

Participant milestones

Participant milestones
Measure	Moxidectin 2 mg 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Overall Study STARTED	4	4	6	8
Overall Study COMPLETED	3	3	6	8
Overall Study NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Moxidectin 2 mg 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Overall Study Withdrawal by Subject	1	1	0	0

Baseline Characteristics

One subject did not have height or weight measured at Baseline, therefore a BMI could not be derived for this subject hence n=3 for this parameter.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Moxidectin 2 mg n=4 Participants 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg n=4 Participants 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg n=6 Participants 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg n=8 Participants 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=4 Participants	3 Participants n=4 Participants	6 Participants n=6 Participants	7 Participants n=8 Participants	19 Participants n=22 Participants
Age, Categorical >=65 years	1 Participants n=4 Participants	1 Participants n=4 Participants	0 Participants n=6 Participants	1 Participants n=8 Participants	3 Participants n=22 Participants
Age, Continuous	46.5 years STANDARD_DEVIATION 18.88 • n=4 Participants	45.3 years STANDARD_DEVIATION 15.50 • n=4 Participants	27.2 years STANDARD_DEVIATION 9.33 • n=6 Participants	29.4 years STANDARD_DEVIATION 17.26 • n=8 Participants	34.8 years STANDARD_DEVIATION 16.73 • n=22 Participants
Sex: Female, Male Female	4 Participants n=4 Participants	1 Participants n=4 Participants	4 Participants n=6 Participants	4 Participants n=8 Participants	13 Participants n=22 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	3 Participants n=4 Participants	2 Participants n=6 Participants	4 Participants n=8 Participants	9 Participants n=22 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=22 Participants
Race (NIH/OMB) White	2 Participants n=4 Participants	3 Participants n=4 Participants	4 Participants n=6 Participants	8 Participants n=8 Participants	17 Participants n=22 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=6 Participants	0 Participants n=8 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=4 Participants	1 Participants n=4 Participants	2 Participants n=6 Participants	0 Participants n=8 Participants	5 Participants n=22 Participants
Body Mass Index	32.98 kg/m^2 STANDARD_DEVIATION 9.95 • n=4 Participants • One subject did not have height or weight measured at Baseline, therefore a BMI could not be derived for this subject hence n=3 for this parameter.	25.27 kg/m^2 STANDARD_DEVIATION 2.40 • n=3 Participants • One subject did not have height or weight measured at Baseline, therefore a BMI could not be derived for this subject hence n=3 for this parameter.	21.70 kg/m^2 STANDARD_DEVIATION 2.31 • n=6 Participants • One subject did not have height or weight measured at Baseline, therefore a BMI could not be derived for this subject hence n=3 for this parameter.	28.68 kg/m^2 STANDARD_DEVIATION 8.46 • n=8 Participants • One subject did not have height or weight measured at Baseline, therefore a BMI could not be derived for this subject hence n=3 for this parameter.	27.01 kg/m^2 STANDARD_DEVIATION 7.68 • n=21 Participants • One subject did not have height or weight measured at Baseline, therefore a BMI could not be derived for this subject hence n=3 for this parameter.

PRIMARY outcome

Timeframe: 28 days

Population: Per protocol analysis set

Outcome measures

Outcome measures
Measure	Moxidectin 2 mg n=2 Total number of live adult mites 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg n=6 Total number of live adult mites 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg n=8 Total number of live adult mites 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg n=14 Total number of live adult mites 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Mortality Rate for Adult Scabies Mites Number of live adult mites assessed at Baseline	2 Adult mites	6 Adult mites	8 Adult mites	14 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 0-4 hours timepoint	0 Adult mites	0 Adult mites	0 Adult mites	0 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 0-8 hours timepoint	0 Adult mites	1 Adult mites	0 Adult mites	0 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 1 timepoint	0 Adult mites	2 Adult mites	0 Adult mites	0 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 2 timepoint	0 Adult mites	2 Adult mites	1 Adult mites	2 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 3 timepoint	0 Adult mites	2 Adult mites	2 Adult mites	3 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 7 timepoint	0 Adult mites	4 Adult mites	4 Adult mites	9 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 14 timepoint	0 Adult mites	5 Adult mites	8 Adult mites	12 Adult mites
Mortality Rate for Adult Scabies Mites Number of dead adult mites assessed at Day 28 timepoint	0 Adult mites	6 Adult mites	8 Adult mites	14 Adult mites

PRIMARY outcome

Timeframe: Day 0 to Day 28 inclusive

Population: The Safety Analysis Set (SfAS) included all subjects exposed to study drug. Subjects were analyzed according to the actual dose of study drug received regardless of their randomized dose group. Unless otherwise noted, the SfAS was used for all safety analyses. Reported data table represent the number of participants with most commonly occurring Adverse Events by Preferred Term.

No formal statistical analysis of AEs was undertaken. Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of Investigational Product (Moxidectin). Moxidectin was generally well tolerated, with no treatment-related SAEs reported and no treatment emergent adverse event (TEAEs) leading to study withdrawal or resulting in death. Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term. Data up to and including the Day 28 assessment for each subject.

Outcome measures

Outcome measures
Measure	Moxidectin 2 mg n=4 Participants 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg n=4 Participants 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg n=6 Participants 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg n=8 Participants 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) Infections and infestations	3 Participants	3 Participants	5 Participants	5 Participants
Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) Skin and subcutaneous tissue disorder	1 Participants	2 Participants	1 Participants	4 Participants
Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) Nervous system disorders	2 Participants	0 Participants	1 Participants	3 Participants
Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) Psychiatric disorders	2 Participants	0 Participants	1 Participants	0 Participants
Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) Gastrointestinal disorders	0 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 28 inclusive

Population: The Safety Analysis Set (SAS) included all subjects exposed to study drug. Subjects were analyzed according to the actual dose of study drug received regardless of their randomized dose group. Unless otherwise noted, the SfAS was used for all safety analyses.

Number of participants with Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of IP. Data up to and including the Day 28 assessment for each subject. The severity of adverse events were assessed using the Toxicity Grading Scale for Healthy Adult and Adolescent volunteers Enrolled in Preventive Vaccine Clinical Trials.

Outcome measures

Outcome measures
Measure	Moxidectin 2 mg n=4 Participants 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg n=4 Participants 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg n=6 Participants 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg n=8 Participants 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Number of Participants and Severity of Adverse Events Grade 1 TEAEs	1 Participants	1 Participants	4 Participants	5 Participants
Number of Participants and Severity of Adverse Events Grade 2 TEAEs	3 Participants	3 Participants	2 Participants	3 Participants
Number of Participants and Severity of Adverse Events Grade 3 TEAEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants and Severity of Adverse Events Grade 4 TEAEs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)

Population: Pharmacokinetic parameters were calculated and derived using non-compartmental methods. AUC calculation method was linear up log down.

The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).

Outcome measures

Outcome measures
Measure	Moxidectin 2 mg n=4 Participants 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg n=4 Participants 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg n=6 Participants 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg n=8 Participants 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Analysis of Moxidectin Plasma Concentrations AUC0-72 (hr*ng/mL)	229 hr*ng/mL Geometric Coefficient of Variation 45.5	989 hr*ng/mL Geometric Coefficient of Variation 33.7	2200 hr*ng/mL Geometric Coefficient of Variation 40.4	3900 hr*ng/mL Geometric Coefficient of Variation 31.0
Analysis of Moxidectin Plasma Concentrations AUC0-D7 (hr*ng/mL)	276 hr*ng/mL Geometric Coefficient of Variation 50.6	1230 hr*ng/mL Geometric Coefficient of Variation 30.5	2780 hr*ng/mL Geometric Coefficient of Variation 39.5	4770 hr*ng/mL Geometric Coefficient of Variation 35.1
Analysis of Moxidectin Plasma Concentrations AUC0-D14 (hr*ng/mL)	329 hr*ng/mL Geometric Coefficient of Variation 62.8	1540 hr*ng/mL Geometric Coefficient of Variation 27.9	3530 hr*ng/mL Geometric Coefficient of Variation 39.3	5820 hr*ng/mL Geometric Coefficient of Variation 38.1
Analysis of Moxidectin Plasma Concentrations AUC0-D28 (hr*ng/mL)	408 hr*ng/mL Geometric Coefficient of Variation 82.5	1970 hr*ng/mL Geometric Coefficient of Variation 30.0	4670 hr*ng/mL Geometric Coefficient of Variation 41.1	7430 hr*ng/mL Geometric Coefficient of Variation 37.6
Analysis of Moxidectin Plasma Concentrations AUC0-24 (hr*ng/mL)	181 hr*ng/mL Geometric Coefficient of Variation 43.2	744 hr*ng/mL Geometric Coefficient of Variation 37.9	1670 hr*ng/mL Geometric Coefficient of Variation 40.2	2930 hr*ng/mL Geometric Coefficient of Variation 26.8
Analysis of Moxidectin Plasma Concentrations AUC0-48 (hr*ng/mL)	212 hr*ng/mL Geometric Coefficient of Variation 44.2	903 hr*ng/mL Geometric Coefficient of Variation 35.0	2000 hr*ng/mL Geometric Coefficient of Variation 40.7	3560 hr*ng/mL Geometric Coefficient of Variation 29.3

SECONDARY outcome

Timeframe: Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h)

Population: Cmax was calculated and derived using non-compartmental methods.

The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL).

Outcome measures

Outcome measures
Measure	Moxidectin 2 mg n=4 Participants 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg n=4 Participants 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg n=6 Participants 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg n=8 Participants 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Analysis of Moxidectin Maximum Plasma Concentrations (Cmax)	21.0 Cmax (ng/mL) Geometric Coefficient of Variation 47.1	73.5 Cmax (ng/mL) Geometric Coefficient of Variation 42.0	207 Cmax (ng/mL) Geometric Coefficient of Variation 44.9	277 Cmax (ng/mL) Geometric Coefficient of Variation 26.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

The severity of pruritus will be determined using the Numerical Rating Scale where 0="no itch" and 10="worst itch imaginable"

Outcome measures

Outcome data not reported

Adverse Events

Moxidectin 2 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Moxidectin 8 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Moxidectin 20 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Moxidectin 36 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Moxidectin 2 mg n=4 participants at risk 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets	Moxidectin 8 mg n=4 participants at risk 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets	Moxidectin 20 mg n=6 participants at risk 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets	Moxidectin 36 mg n=8 participants at risk 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/4 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.	0.00% 0/4 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.	0.00% 0/6 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.	12.5% 1/8 • Number of events 1 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/4 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.	0.00% 0/4 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.	0.00% 0/6 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.	12.5% 1/8 • Number of events 1 • Day 0 to Week 12, inclusive. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.

Other adverse events

Additional Information

Clinical Project Manager

Medicines Development for Global Health Limited

Phone: +61 399122400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution agrees that no Publication of the Study results may be made until Publication of the results of the Study or 2 years after Study Completion, whichever is the sooner. The Institution must ensure that the Discloser gives a copy of any proposed Publication drafted by them and/or other Personnel involved in the conduct of the Study to the Sponsor at least 40 days before forwarding it to any person that is not bound by the confidentiality obligations
Publication restrictions are in place

Restriction type: OTHER