Trial Outcomes & Findings for A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis (NCT NCT00784693)

Last Updated: 2021-04-30

Results Overview

Participants assessed daily endometriosis pain on an 11-point Numeric Rating Scale (NRS) of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2021-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Overall Study STARTED	23	25
Overall Study Treated	22	25
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Tanezumab A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Overall Study Lost to Follow-up	0	1
Overall Study Lack of Efficacy	1	1
Overall Study Withdrawal by Subject	0	4
Overall Study Randomized but not Treated	1	0
Overall Study Other	1	0

Baseline Characteristics

A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tanezumab n=22 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=25 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.	Total n=47 Participants Total of all reporting groups
Age, Continuous	30 years STANDARD_DEVIATION 6.7 • n=93 Participants	30.4 years STANDARD_DEVIATION 6.4 • n=4 Participants	30.2 years STANDARD_DEVIATION 6.4 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	25 Participants n=4 Participants	47 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Restricted full analysis set (rFAS) included all randomized participants who received at least 1 dose of study medication and completed \>=12 days of baseline observation period and who had provided baseline and primary efficacy data for \>=12 days of the baseline and \>=15 days of each of first 2 post-randomization 28-day observation periods.

Outcome measures

Outcome measures
Measure	Tanezumab n=19 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 Baseline	5.45 units on a scale Standard Deviation 1.218	5.50 units on a scale Standard Deviation 1.363
Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 Change at Week 8	-2.88 units on a scale Standard Deviation 2.653	-3.51 units on a scale Standard Deviation 1.714

SECONDARY outcome

Timeframe: Weeks 4, 12, and 16

Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.

Participants assessed daily endometriosis pain on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.

Outcome measures

Outcome measures
Measure	Tanezumab n=19 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 Week 4	3.55 units on a scale Standard Deviation 1.999	2.94 units on a scale Standard Deviation 1.814
Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 Week 12	2.22 units on a scale Standard Deviation 2.113	1.45 units on a scale Standard Deviation 1.631
Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 Week 16	3.12 units on a scale Standard Deviation 2.320	2.15 units on a scale Standard Deviation 2.338

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.

Endometriosis pain during menstruation was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Tanezumab n=18 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=15 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Baseline	6.04 units on a scale Standard Deviation 1.377	6.54 units on a scale Standard Deviation 1.756
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 4	3.98 units on a scale Standard Deviation 2.503	3.72 units on a scale Standard Deviation 2.155
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 8	2.99 units on a scale Standard Deviation 2.724	2.18 units on a scale Standard Deviation 1.540
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 12	2.92 units on a scale Standard Deviation 2.801	1.52 units on a scale Standard Deviation 2.117
Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 16	4.66 units on a scale Standard Deviation 2.297	2.94 units on a scale Standard Deviation 2.847

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.

Non-menstrual endometriosis pain was derived from the average endometriosis pain severity as recorded on an 11-point NRS of 0 to 10 (0 = no pain and 10 = pain as bad as you can imagine) on the non-menstrual days for the 28-day period in baseline observation period and preceding each post-baseline visit. Higher score indicated greater pain.

Outcome measures

Outcome measures
Measure	Tanezumab n=19 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Baseline	5.25 units on a scale Standard Deviation 1.617	5.21 units on a scale Standard Deviation 1.348
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 4	3.42 units on a scale Standard Deviation 1.935	2.77 units on a scale Standard Deviation 1.885
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 8	2.38 units on a scale Standard Deviation 2.240	1.81 units on a scale Standard Deviation 2.038
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 12	1.98 units on a scale Standard Deviation 2.124	1.33 units on a scale Standard Deviation 1.513
Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 16	2.86 units on a scale Standard Deviation 2.341	1.91 units on a scale Standard Deviation 2.288

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.

Participants assessed worst endometriosis pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.

Outcome measures

Outcome measures
Measure	Tanezumab n=19 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 12	3.02 units on a scale Standard Deviation 2.612	2.18 units on a scale Standard Deviation 2.465
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Baseline	6.20 units on a scale Standard Deviation 1.265	6.84 units on a scale Standard Deviation 1.297
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 4	4.21 units on a scale Standard Deviation 2.053	4.00 units on a scale Standard Deviation 2.216
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 8	3.20 units on a scale Standard Deviation 2.465	2.64 units on a scale Standard Deviation 2.373
Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 16	3.87 units on a scale Standard Deviation 2.477	3.12 units on a scale Standard Deviation 2.818

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Participants assessed worst endometriosis pain during menstruation in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores over the episode of menstruation (at least 3 days of spotting or bleeding) for the 28-day period preceding the post-baseline visit.

Outcome measures

Outcome measures
Measure	Tanezumab n=18 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=15 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Baseline	6.98 units on a scale Standard Deviation 1.084	7.67 units on a scale Standard Deviation 1.632
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 4	4.78 units on a scale Standard Deviation 2.532	5.02 units on a scale Standard Deviation 2.488
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 8	3.60 units on a scale Standard Deviation 3.022	3.19 units on a scale Standard Deviation 2.356
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 12	3.58 units on a scale Standard Deviation 3.198	2.34 units on a scale Standard Deviation 3.072
Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 Week 16	5.54 units on a scale Standard Deviation 2.752	4.03 units on a scale Standard Deviation 3.306

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.

Participants assessed worst endometriosis non-menstrual pain in the last 24 hours on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period in the baseline observation period. Post-baseline value was calculated as mean of the scores on non-menstrual days for the 28-day period preceding the post-baseline visit.

Outcome measures

Outcome measures
Measure	Tanezumab n=19 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Baseline	5.86 units on a scale Standard Deviation 1.629	6.60 units on a scale Standard Deviation 1.299
Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 4	4.06 units on a scale Standard Deviation 2.038	3.75 units on a scale Standard Deviation 2.360
Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 8	2.99 units on a scale Standard Deviation 2.331	2.37 units on a scale Standard Deviation 2.527
Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 12	2.79 units on a scale Standard Deviation 2.646	2.03 units on a scale Standard Deviation 2.358
Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 Week 16	3.61 units on a scale Standard Deviation 2.475	2.85 units on a scale Standard Deviation 2.807

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Pain related to sexual intercourse was defined as the discomfort or pain that may occur during or after sexual intercourse with vaginal penetration. Participants assessed pain during or after sexual intercourse on an 11-point NRS of 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Higher score indicated greater pain. Baseline value was calculated as mean of the scores over 28 days in the baseline observation period. Post-baseline value was calculated as mean of the scores over the 28-day period preceding the post-baseline visit.

Outcome measures

Outcome measures
Measure	Tanezumab n=15 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=14 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 Baseline	5.21 units on a scale Standard Deviation 3.209	5.19 units on a scale Standard Deviation 2.757
Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 Week 4	3.32 units on a scale Standard Deviation 2.687	3.03 units on a scale Standard Deviation 2.298
Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 Week 8	2.70 units on a scale Standard Deviation 2.884	2.92 units on a scale Standard Deviation 2.869
Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 Week 12	2.99 units on a scale Standard Deviation 2.485	2.57 units on a scale Standard Deviation 2.337
Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 Week 16	3.29 units on a scale Standard Deviation 2.976	3.05 units on a scale Standard Deviation 2.442

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Investigator assessed the severity of the dysmenorrhea (menstrual pain), pelvic pain and dyspareunia (painful sexual intercourse) experienced by participants occurring during the most recent menstrual cycle on a 4-point scale, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Total score was calculated as a sum of the individual pain scores for dysmenorrhea, dyspareunia and pelvic pain. The total score range: 0 (no pain) to 9 (worst possible pain).

Outcome measures

Outcome measures
Measure	Tanezumab n=12 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=14 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 Baseline	7.08 units on a scale Standard Deviation 1.379	7.00 units on a scale Standard Deviation 1.109
Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 Week 4	5.00 units on a scale Standard Deviation 1.871	4.58 units on a scale Standard Deviation 2.712
Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 Week 8	2.89 units on a scale Standard Deviation 2.571	3.83 units on a scale Standard Deviation 2.443
Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 Week 12	3.42 units on a scale Standard Deviation 2.575	2.63 units on a scale Standard Deviation 1.996
Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 Week 16	4.83 units on a scale Standard Deviation 3.070	3.17 units on a scale Standard Deviation 2.791

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable for specified category for each treatment arm, respectively.

EHP-30 is a validated quality of life (QoL) scale assessing emotional, physical and sexual function. EHP-30 consists of 30 items that assess the frequency of physical and mental manifestations of endometriosis during the previous 4 weeks on a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always).. Scores for 6 domains (pain, control and powerlessness, emotional well-being, social support, self image, and sexual intercourse) were obtained as a sum of all relevant item scores and transformed to a 0 to 100 score range. Each domain score ranges from 0 (best possible health status) to 100 (worst possible health status).

Outcome measures

Outcome measures
Measure	Tanezumab n=19 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=16 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Baseline: Pain	58.97 units on a scale Standard Deviation 14.661	56.68 units on a scale Standard Deviation 13.213
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Baseline: Control & Powerlessness	69.96 units on a scale Standard Deviation 20.250	64.84 units on a scale Standard Deviation 22.098
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Baseline: Emotional well-being	52.85 units on a scale Standard Deviation 18.005	41.15 units on a scale Standard Deviation 21.671
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Baseline: Social support	57.57 units on a scale Standard Deviation 24.701	46.48 units on a scale Standard Deviation 26.018
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Baseline: Self-image	53.51 units on a scale Standard Deviation 29.700	45.31 units on a scale Standard Deviation 27.550
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Baseline: Sexual intercourse	58.93 units on a scale Standard Deviation 37.835	65.36 units on a scale Standard Deviation 23.490
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Week 8: Pain	28.34 units on a scale Standard Deviation 17.179	26.30 units on a scale Standard Deviation 23.325
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Week 8: Control & Powerlessness	28.92 units on a scale Standard Deviation 20.437	27.98 units on a scale Standard Deviation 34.298
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Week 8: Emotional well-being	27.94 units on a scale Standard Deviation 17.664	16.37 units on a scale Standard Deviation 19.300
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Week 8: Social support	36.33 units on a scale Standard Deviation 28.706	26.34 units on a scale Standard Deviation 30.636
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Week 8: Self-image	31.86 units on a scale Standard Deviation 23.613	24.40 units on a scale Standard Deviation 27.632
Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 Week 8: Sexual intercourse	45.45 units on a scale Standard Deviation 32.822	29.20 units on a scale Standard Deviation 31.654

SECONDARY outcome

Timeframe: Week 8

Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

GRA questionnaire is a 7-point symmetric scale which measures participant-reported overall response to treatment compared to baseline as 1 of the following possible responses: markedly worse, moderately worse, slightly worse, no change, slightly improved, moderately improved, and markedly improved. Number of participants with each response is reported.

Outcome measures

Outcome measures
Measure	Tanezumab n=17 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=14 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Global Response Assessment (GRA) at Week 8 Markedly Worse	0 Participants	1 Participants
Global Response Assessment (GRA) at Week 8 Moderately Worse	0 Participants	0 Participants
Global Response Assessment (GRA) at Week 8 Slightly Worse	0 Participants	0 Participants
Global Response Assessment (GRA) at Week 8 No Change	3 Participants	2 Participants
Global Response Assessment (GRA) at Week 8 Slightly Improved	4 Participants	2 Participants
Global Response Assessment (GRA) at Week 8 Moderately Improved	8 Participants	6 Participants
Global Response Assessment (GRA) at Week 8 Markedly Improved	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 8

Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant's response is rated on a 5-point scale where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. Number of participants with each response is reported.

Outcome measures

Outcome measures
Measure	Tanezumab n=17 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=14 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Participant Global Satisfaction at Week 8 Dissatisfied	0 Participants	0 Participants
Participant Global Satisfaction at Week 8 Extremely satisfied	5 Participants	3 Participants
Participant Global Satisfaction at Week 8 Satisfied	7 Participants	7 Participants
Participant Global Satisfaction at Week 8 Neither satisfied nor dissatisfied	5 Participants	2 Participants
Participant Global Satisfaction at Week 8 Extremely dissatisfied	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 8

Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participant global preference is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant reported previous treatment under following categories: hormonal contraceptive, painkiller, and hormone treatment by injection, hormone treatment by tablet, surgery, and no treatment. Participant preference was assessed using following categories: definitely prefer study medication, slightly prefer study medication, no preference, slightly prefer previous treatment, and definitely prefer previous treatment. Number of participants under each of the categories is reported. For previous treatment, a single participant may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure	Tanezumab n=17 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=14 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Participant Global Preference at Week 8 Hormonal contraceptive	7 Participants	7 Participants
Participant Global Preference at Week 8 Painkiller	11 Participants	7 Participants
Participant Global Preference at Week 8 Hormone treatment by injection	1 Participants	1 Participants
Participant Global Preference at Week 8 Hormone treatment by tablet	1 Participants	0 Participants
Participant Global Preference at Week 8 Surgery	5 Participants	5 Participants
Participant Global Preference at Week 8 No treatment	4 Participants	1 Participants
Participant Global Preference at Week 8 Definitely prefer study medication	11 Participants	6 Participants
Participant Global Preference at Week 8 Slightly prefer study medication	3 Participants	3 Participants
Participant Global Preference at Week 8 No preference	0 Participants	2 Participants
Participant Global Preference at Week 8 Slightly prefer previous treatment	1 Participants	1 Participants
Participant Global Preference at Week 8 Definitely prefer previous treatment	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 8

Population: Restricted FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure.

Participant willingness to re-use study medication is assessed using PRTI, which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participant willingness to re-use study medication was assessed using following categories: definitely want to re-use, might want to re-use, not sure, might not want to re-use, definitely would not want to re-use.

Outcome measures

Outcome measures
Measure	Tanezumab n=17 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=14 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Participant Willingness to Re-use Study Medication Definitely want to re-use	13 Participants	7 Participants
Participant Willingness to Re-use Study Medication Might want to re-use	1 Participants	1 Participants
Participant Willingness to Re-use Study Medication Not sure	2 Participants	3 Participants
Participant Willingness to Re-use Study Medication Might not want to re-use	1 Participants	1 Participants
Participant Willingness to Re-use Study Medication Definitely would not want to re-use	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1, Week 8, and Week 16 (End of Treatment)

Population: FAS. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.

Outcome measures

Outcome measures
Measure	Tanezumab n=21 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=24 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Plasma Nerve Growth Factor (NGF) Concentration Day 1	301 picogram per milliliter (pg/mL) Standard Deviation 1217	32.7 picogram per milliliter (pg/mL) Standard Deviation 10.6
Plasma Nerve Growth Factor (NGF) Concentration Week 8	4053 picogram per milliliter (pg/mL) Standard Deviation 1276	30.7 picogram per milliliter (pg/mL) Standard Deviation 7.8
Plasma Nerve Growth Factor (NGF) Concentration Week 16	3010 picogram per milliliter (pg/mL) Standard Deviation 921	31.4 picogram per milliliter (pg/mL) Standard Deviation 10.6

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, and 16

Mean amount of daily rescue medication (acetaminophen 500 mg tablet/capsule) taken for endometriosis associated pain (in mg) was assessed.

Outcome measures

Outcome measures
Measure	Tanezumab n=18 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=15 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Amount of Rescue Medication Used Week 8	34.73 mg/day Standard Deviation 37.21	43.20 mg/day Standard Deviation 28.95
Amount of Rescue Medication Used Baseline	66.78 mg/day Standard Deviation 34.60	56.60 mg/day Standard Deviation 61.39
Amount of Rescue Medication Used Week 4	41.78 mg/day Standard Deviation 38.69	48.86 mg/day Standard Deviation 50.57
Amount of Rescue Medication Used Week 12	21.25 mg/day Standard Deviation 20.57	29.33 mg/day Standard Deviation 28.09
Amount of Rescue Medication Used Week 16	24.13 mg/day Standard Deviation 27.33	28.40 mg/day Standard Deviation 25.81

SECONDARY outcome

Timeframe: Baseline up to 113 days after last dose of study medication

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 113 days after last dose that were absent before treatment or worsened relative to pre-treatment state.

Outcome measures

Outcome measures
Measure	Tanezumab n=22 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=25 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	16 Participants	21 Participants
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, and 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively.

A neurological evaluation was performed by a consulting neurologist if adverse events suggested new or worsening peripheral neuropathy with respect to baseline or any adverse event of abnormal peripheral sensation was recorded. A neurological evaluation was done as soon as the above signs and symptoms were known, preferably within 7 days of becoming aware of such problems if possible. Neurological evaluation was done using Neuropathy Impairment Score (NIS) by investigator. Neurologic examination assessment included strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes. Abnormality was judged by the investigator.

Outcome measures

Outcome measures
Measure	Tanezumab n=22 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=23 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Number of Participants With New or Worsened Neurological Examinations Week 2	3 Participants	1 Participants
Number of Participants With New or Worsened Neurological Examinations Week 4	0 Participants	0 Participants
Number of Participants With New or Worsened Neurological Examinations Week 8	1 Participants	1 Participants
Number of Participants With New or Worsened Neurological Examinations Week 12	1 Participants	2 Participants
Number of Participants With New or Worsened Neurological Examinations Week 16	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (pre-dose), Weeks 2, 4, 8, and 16

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable at specified time point. Only participants who received tanezumab were planned to be analyzed for this outcome measure.

Serum samples were analyzed for the presence or absence of anti-tanezumab antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Tanezumab n=22 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Number of Participants With Anti-Drug Antibody (ADA) Day 1	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 2	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 4	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 8	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Week 16	0 Participants	—

SECONDARY outcome

Timeframe: Screening, Weeks 2, 4, 8, 12, and Early termination

Population: Safety analysis set included all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Tanezumab n=22 Participants A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=23 Participants A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Number of Participants With Positive Urine or Serum Pregnancy Test	0 Participants	0 Participants

Adverse Events

Tanezumab

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tanezumab n=22 participants at risk A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	Placebo n=25 participants at risk A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Gastrointestinal disorders Abdominal pain	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Nausea	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
General disorders Chest pain	0.00% 0/22 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER