Trial Outcomes & Findings for Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle (NCT NCT02817464)
NCT ID: NCT02817464
Last Updated: 2024-02-12
Results Overview
'Overall number of participants analyzed' = participants evaluable for this outcome measure.
COMPLETED
PHASE1
12 participants
Day 1
2024-02-12
Participant Flow
This was a 2-part study: Part 1 (Exploratory Pharmacokinetics \[PK\]) and Part 2 (Dose-range Finding).
Due to suboptimal long-term stability and re-suspendability of the TV-46046 formulation, the decision was made not to initiate Part 2 of this clinical study, and to conduct a new dose-range finding study. Participants were planned to be assigned sequentially in 3 treatment groups in Part 1. The results of the first 2 groups did not warrant the evaluation of the intermediate concentration of TV-46046 and treatment group 3 was therefore not enrolled.
Participant milestones
| Measure |
Group 1 (TV-46046 - Undiluted)
Participants received a single subcutaneous (SC) injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (TV-46046 - Undiluted)
Participants received a single subcutaneous (SC) injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Discontinued early due to personal decision
|
1
|
1
|
Baseline Characteristics
Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
Baseline characteristics by cohort
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 4.04 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 5.08 • n=7 Participants
|
31.8 years
STANDARD_DEVIATION 5.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in their baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; body mass index (BMI) outside the eligible range; or use of drugs known to impact ovulation or pharmacokinetic (PK) of MPA (with the exception of selective cyclooxygenase-2 \[COX-2\] inhibitors that were taken for \<5 consecutive days).
'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=5 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Serum Medroxyprogesterone Acetate (MPA) Concentration at Day 1
|
0.36 nanograms (ng)/milliliter (mL)
Standard Deviation 0.13
|
0.67 nanograms (ng)/milliliter (mL)
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: Day 7Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=5 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Serum MPA Concentration at Day 7
|
0.37 ng/mL
Standard Deviation 0.10
|
0.70 ng/mL
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: Day 28Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Serum MPA Concentration at Day 28
|
0.36 ng/mL
Standard Deviation 0.07
|
0.69 ng/mL
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: Day 91Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Serum MPA Concentration at Day 91
|
0.41 ng/mL
Standard Deviation 0.13
|
0.62 ng/mL
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Day 182Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=5 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Serum MPA Concentration at Day 182
|
0.22 ng/mL
Standard Deviation 0.08
|
0.17 ng/mL
Standard Deviation 0.10
|
PRIMARY outcome
Timeframe: Day 210Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=5 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=5 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Serum MPA Concentration at Day 210
|
0.20 ng/mL
Standard Deviation 0.05
|
0.12 ng/mL
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Day 0 up to Week 52Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Maximum Observed Serum Concentration (Cmax) of MPA
|
0.53 ng/mL
Interval 0.43 to 0.64
|
0.97 ng/mL
Interval 0.73 to 1.29
|
PRIMARY outcome
Timeframe: Day 182Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days). Overall number of participants analyzed= participants evaluable for this outcome measure.
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=5 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Observed Serum Drug Concentration at Day 182 (C182) of MPA
|
0.21 ng/mL
Interval 0.14 to 0.31
|
0.14 ng/mL
Interval 0.05 to 0.4
|
PRIMARY outcome
Timeframe: Day 0 up to Week 52Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Time to Reach Cmax (Tmax) of MPA
|
9.49 days
Interval 1.96 to 40.96
|
47.99 days
Interval 7.1 to 84.01
|
PRIMARY outcome
Timeframe: Day 0 up to Day 182Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 182 (AUC0-182) of MPA
|
58.61 days*ng/mL
Interval 44.75 to 76.76
|
97.72 days*ng/mL
Interval 82.2 to 116.18
|
PRIMARY outcome
Timeframe: Day 0 up to Day 210Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Day 210 (AUC0-210) of MPA
|
63.91 days*ng/mL
Interval 48.78 to 83.74
|
103.11 days*ng/mL
Interval 88.4 to 120.27
|
PRIMARY outcome
Timeframe: Day 0 up to Week 52Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Area Under the Serum Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-∞) of MPA
|
94.56 days*ng/mL
Interval 81.16 to 110.16
|
114.13 days*ng/mL
Interval 98.77 to 131.88
|
PRIMARY outcome
Timeframe: Day 0 up to Week 52Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Apparent Terminal Half-life (t1/2) of MPA
|
82.87 days
Interval 32.12 to 213.8
|
42.34 days
Interval 23.2 to 77.28
|
PRIMARY outcome
Timeframe: Day 0 up to Week 78Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Week 78Population: Primary evaluable population: a subset of treated population, excluding participants who had detectable MPA in baseline specimen or for whom a major protocol violation occurred at enrollment, including: absence of a confirmed ovulation in pre-treatment period; BMI outside eligible range; or use of drugs that impact ovulation or PK of MPA (exception: selective COX-2 inhibitors taken for \<5 consecutive days).
Ovulation was defined as a single elevated serum progesterone ≥4.7 ng/mL. Time to ovulation was computed as the difference in days between detection of the first post-randomization elevated progesterone and the date of treatment initiation. Median time to ovulation was derived using Kaplan-Meier estimate.
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Part 1: Time to Ovulation
|
328 days
Interval 279.0 to 434.0
|
251 days
Interval 196.0 to 291.0
|
SECONDARY outcome
Timeframe: Day 0 up to Week 52Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Week 52Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Day 210Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Day 182Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Day 182Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Day 210Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Week 52Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Week 52Population: Data for this outcome measure were not collected and analyzed as Part 2 of the study was not initiated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 up to Week 78Population: Treated population included all screened participants who were enrolled and received a dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Outcome measures
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 Participants
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 Participants
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
6 Participants
|
6 Participants
|
Adverse Events
Group 1 (TV-46046 - Undiluted)
Group 2 (TV-46046 - Saline-diluted)
Serious adverse events
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 participants at risk
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 participants at risk
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
Other adverse events
| Measure |
Group 1 (TV-46046 - Undiluted)
n=6 participants at risk
Participants received a single SC injection of undiluted TV-46046.
|
Group 2 (TV-46046 - Saline-diluted)
n=6 participants at risk
Participants received a single SC injection of saline-diluted TV-46046.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
General disorders
Chest pain
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
General disorders
Injection site reaction
|
83.3%
5/6 • Number of events 5 • Day 0 up to Week 78
|
66.7%
4/6 • Number of events 4 • Day 0 up to Week 78
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
General disorders
Thirst
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Immune system disorders
Urticaria
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Infections and infestations
Bacterial vaginosis
|
33.3%
2/6 • Number of events 2 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Infections and infestations
Gastroenteritis viral
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Infections and infestations
Viral upper respiratory tract infection
|
33.3%
2/6 • Number of events 3 • Day 0 up to Week 78
|
33.3%
2/6 • Number of events 3 • Day 0 up to Week 78
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Injury, poisoning and procedural complications
Chest injury
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Injury, poisoning and procedural complications
Foot fracture
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Injury, poisoning and procedural complications
Nose injury
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 3 • Day 0 up to Week 78
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Investigations
Weight gain
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 2 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
0.00%
0/6 • Day 0 up to Week 78
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Day 0 up to Week 78
|
33.3%
2/6 • Number of events 2 • Day 0 up to Week 78
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/6 • Day 0 up to Week 78
|
16.7%
1/6 • Number of events 1 • Day 0 up to Week 78
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER