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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00784693
• Collaborator: (none)
• Enrollment: 48
• Locations: 30
• Arms: 2
• Actual Duration (Months): 15.5
• Patients Per Site: 1.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Biological: Tanezumab; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED, PARALLEL GROUP PROOF OF CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH ENDOMETRIOSIS
• Actual Study Start Date: Dec 18, 2008
• Actual Primary Completion Date: Jan 27, 2010
• Actual Study Completion Date: Apr 5, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tanezumab	Biological: Tanezumab; 15 mg IV single dose
Placebo Comparator: Placebo	Drug: Placebo; Placebo IV single dose

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 [Baseline, Week 8]

   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.

Secondary Outcome Measures

1. Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 [Weeks 4, 12, and 16]

   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.

2. Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 [Baseline, Weeks 4, 8, 12, and 16]

   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.

3. Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 [Baseline, Weeks 4, 8, 12, and 16]

   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.

4. Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 [Baseline, Weeks 4, 8, 12, and 16]

   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.

5. Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 [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.

6. Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 [Baseline, Weeks 4, 8, 12, and 16]

   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.

7. Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 [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.

8. Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 [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).

9. Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 [Baseline and Week 8]

   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).

10. Global Response Assessment (GRA) at Week 8 [Week 8]

    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.

11. Participant Global Satisfaction at Week 8 [Week 8]

    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.

12. Participant Global Preference at Week 8 [Week 8]

    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.

13. Participant Willingness to Re-use Study Medication [Week 8]

    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.

14. Plasma Nerve Growth Factor (NGF) Concentration [Day 1, Week 8, and Week 16 (End of Treatment)]

15. Amount of Rescue Medication Used [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.

16. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 113 days after last 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.

17. Number of Participants With New or Worsened Neurological Examinations [Weeks 2, 4, 8, 12, and 16]

    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.

18. Number of Participants With Anti-Drug Antibody (ADA) [Day 1 (pre-dose), Weeks 2, 4, 8, and 16]

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

19. Number of Participants With Positive Urine or Serum Pregnancy Test [Screening, Weeks 2, 4, 8, 12, and Early termination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pre-menstrual women with moderate to severe endometriosis. The diagnosis of endometriosis must have been confirmed surgically within the last 8 years.

• Subjects should have regular menstrual cycle (21 - 35 days) and must be willing to use adequate contraception (2 forms of birth control, one of which must be a barrier method). Contraception is required throughout the study (screening to 16 weeks post treatment), even if subjects discontinue prematurely.

Exclusion Criteria:

• Previous hysterectomy

• Surgical treatment for endometriosis within last 6 months.

• Medical treatment for endometriosis other than combined oral contraceptive pill within the last 3 months

• Current use of the coil or progesterone only contraceptive (the combined oral contraceptive pill is allowed).

• Any history of malignant disease (cancer)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bay Area Physicians for Women	Mobile	Alabama	United States	36608
2	Springhill Medical Center	Mobile	Alabama	United States	36608
3	Wilmax Clinical Research	Mobile	Alabama	United States	36608
4	Visions Clinical Research - Tucson	Tucson	Arizona	United States	85712
5	Genesis Center for Clinical Research	San Diego	California	United States	92103
6	Medical Center for Clinical Research	San Diego	California	United States	92108
7	Visions Clinical Research	Boynton Beach	Florida	United States	33472
8	Nature Coast Clinical Research, LLC	Crystal River	Florida	United States	34429
9	Jacksonville Center for Clnical Research	Jacksonville	Florida	United States	32216
10	Advanced Women's Healthcare	West Palm Beach	Florida	United States	33409
11	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida	United States	33409
12	Mount Vernon Clinical Research	Atlanta	Georgia	United States	30328
13	Radiant Research	Overland Park	Kansas	United States	66202
14	Women's Healthcare Group	Overland Park	Kansas	United States	66215
15	N.E.C.C.R, Fall River LLC	Fall River	Massachusetts	United States	02720
16	Beyer Research - Women's Health Care Specialists, PC	Paw Paw	Michigan	United States	49079
17	Women's Clinic of Lincoln, PC	Lincoln	Nebraska	United States	68510
18	Lyndhurst Clinical Research	Kernersville	North Carolina	United States	27284
19	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
20	Columbus Center for Women's Health Research	Columbus	Ohio	United States	43213
21	Planned Parenthood of Arkansas and Eastern Oklahoma	Tulsa	Oklahoma	United States	74105
22	Allegheny Pain Management	Altoona	Pennsylvania	United States	16602
23	Greenville Hospital System University Medical Group, Department of OB/GYN	Greenville	South Carolina	United States	29605
24	ClinSearch, LLC	Chattanooga	Tennessee	United States	37421
25	Whitaker's Women Care	East Ridge	Tennessee	United States	37412
26	Advances In Health, Inc.	Houston	Texas	United States	77030
27	Allon Health Care	Houston	Texas	United States	77079
28	Old Farm Obstetrics and Gynecology	Salt Lake City	Utah	United States	84107
29	Salt Lake Research	Salt Lake City	Utah	United States	84107
30	Women's Clinical Research Center	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00784693
• Other Study ID Numbers: A4091023; ENDOMETRIOSIS POC
• First Posted: Nov 4, 2008
• Last Update Posted: Apr 30, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pfizer: Endometriosis; pain; tanezumab; nerve growth factor; questionnaires
• Additional relevant MeSH terms: Endometriosis; Tanezumab

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Tanezumab	Placebo	Total
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.	Total of all reporting groups
Overall Participants	22	25	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30 (6.7)	30.4 (6.4)	30.2 (6.4)
Sex: Female, Male (Count of Participants)
Female	22 100%	25 100%	47 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average Daily Endometriosis Pain Score at Week 8
Description	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.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	19	16
Baseline	5.45 (1.218)	5.50 (1.363)
Change at Week 8	-2.88 (2.653)	-3.51 (1.714)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tanezumab, Placebo
	Comments	Week 8: Analysis was based on analysis of co-variance (ANCOVA) model with main effects of treatment, contraceptive use and baseline severity of pain.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 90%; -0.87 to 1.69
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.75
	Estimation Comments

2. Secondary Outcome

Title	Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16
Description	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.
Time Frame	Weeks 4, 12, and 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	19	16
Week 4	3.55 (1.999)	2.94 (1.814)
Week 12	2.22 (2.113)	1.45 (1.631)
Week 16	3.12 (2.320)	2.15 (2.338)

3. Secondary Outcome

Title	Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Description	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.
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	18	15
Baseline	6.04 (1.377)	6.54 (1.756)
Week 4	3.98 (2.503)	3.72 (2.155)
Week 8	2.99 (2.724)	2.18 (1.540)
Week 12	2.92 (2.801)	1.52 (2.117)
Week 16	4.66 (2.297)	2.94 (2.847)

4. Secondary Outcome

Title	Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Description	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.
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	19	16
Baseline	5.25 (1.617)	5.21 (1.348)
Week 4	3.42 (1.935)	2.77 (1.885)
Week 8	2.38 (2.240)	1.81 (2.038)
Week 12	1.98 (2.124)	1.33 (1.513)
Week 16	2.86 (2.341)	1.91 (2.288)

5. Secondary Outcome

Title	Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Description	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.
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	19	16
Baseline	6.20 (1.265)	6.84 (1.297)
Week 4	4.21 (2.053)	4.00 (2.216)
Week 8	3.20 (2.465)	2.64 (2.373)
Week 12	3.02 (2.612)	2.18 (2.465)
Week 16	3.87 (2.477)	3.12 (2.818)

6. Secondary Outcome

Title	Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16
Description	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.
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	18	15
Baseline	6.98 (1.084)	7.67 (1.632)
Week 4	4.78 (2.532)	5.02 (2.488)
Week 8	3.60 (3.022)	3.19 (2.356)
Week 12	3.58 (3.198)	2.34 (3.072)
Week 16	5.54 (2.752)	4.03 (3.306)

7. Secondary Outcome

Title	Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16
Description	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.
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	19	16
Baseline	5.86 (1.629)	6.60 (1.299)
Week 4	4.06 (2.038)	3.75 (2.360)
Week 8	2.99 (2.331)	2.37 (2.527)
Week 12	2.79 (2.646)	2.03 (2.358)
Week 16	3.61 (2.475)	2.85 (2.807)

8. Secondary Outcome

Title	Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16
Description	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.
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	15	14
Baseline	5.21 (3.209)	5.19 (2.757)
Week 4	3.32 (2.687)	3.03 (2.298)
Week 8	2.70 (2.884)	2.92 (2.869)
Week 12	2.99 (2.485)	2.57 (2.337)
Week 16	3.29 (2.976)	3.05 (2.442)

9. Secondary Outcome

Title	Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16
Description	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).
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	12	14
Baseline	7.08 (1.379)	7.00 (1.109)
Week 4	5.00 (1.871)	4.58 (2.712)
Week 8	2.89 (2.571)	3.83 (2.443)
Week 12	3.42 (2.575)	2.63 (1.996)
Week 16	4.83 (3.070)	3.17 (2.791)

10. Secondary Outcome

Title	Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8
Description	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).
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

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

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

11. Secondary Outcome

Title	Global Response Assessment (GRA) at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	17	14
Markedly Worse	0 0%	1 4%
Moderately Worse	0 0%	0 0%
Slightly Worse	0 0%	0 0%
No Change	3 13.6%	2 8%
Slightly Improved	4 18.2%	2 8%
Moderately Improved	8 36.4%	6 24%
Markedly Improved	2 9.1%	3 12%

12. Secondary Outcome

Title	Participant Global Satisfaction at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	17	14
Extremely satisfied	5 22.7%	3 12%
Satisfied	7 31.8%	7 28%
Neither satisfied nor dissatisfied	5 22.7%	2 8%
Dissatisfied	0 0%	0 0%
Extremely dissatisfied	0 0%	2 8%

13. Secondary Outcome

Title	Participant Global Preference at Week 8
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	17	14
Hormonal contraceptive	7 31.8%	7 28%
Painkiller	11 50%	7 28%
Hormone treatment by injection	1 4.5%	1 4%
Hormone treatment by tablet	1 4.5%	0 0%
Surgery	5 22.7%	5 20%
No treatment	4 18.2%	1 4%
Definitely prefer study medication	11 50%	6 24%
Slightly prefer study medication	3 13.6%	3 12%
No preference	0 0%	2 8%
Slightly prefer previous treatment	1 4.5%	1 4%
Definitely prefer previous treatment	2 9.1%	2 8%

14. Secondary Outcome

Title	Participant Willingness to Re-use Study Medication
Description	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.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	17	14
Definitely want to re-use	13 59.1%	7 28%
Might want to re-use	1 4.5%	1 4%
Not sure	2 9.1%	3 12%
Might not want to re-use	1 4.5%	1 4%
Definitely would not want to re-use	0 0%	2 8%

15. Secondary Outcome

Title	Plasma Nerve Growth Factor (NGF) Concentration
Time Frame	Day 1, Week 8, and Week 16 (End of Treatment)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	21	24
Day 1	301 (1217)	32.7 (10.6)
Week 8	4053 (1276)	30.7 (7.8)
Week 16	3010 (921)	31.4 (10.6)

16. Secondary Outcome

Title	Amount of Rescue Medication Used
Description	Mean amount of daily rescue medication (acetaminophen 500 mg tablet/capsule) taken for endometriosis associated pain (in mg) was assessed.
Time Frame	Baseline, Weeks 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	18	15
Baseline	66.78 (34.60)	56.60 (61.39)
Week 4	41.78 (38.69)	48.86 (50.57)
Week 8	34.73 (37.21)	43.20 (28.95)
Week 12	21.25 (20.57)	29.33 (28.09)
Week 16	24.13 (27.33)	28.40 (25.81)

17. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	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.
Time Frame	Baseline up to 113 days after last dose of study medication

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	22	25
AEs	16 72.7%	21 84%
SAEs	0 0%	3 12%

18. Secondary Outcome

Title	Number of Participants With New or Worsened Neurological Examinations
Description	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.
Time Frame	Weeks 2, 4, 8, 12, and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	22	23
Week 2	3 13.6%	1 4%
Week 4	0 0%	0 0%
Week 8	1 4.5%	1 4%
Week 12	1 4.5%	2 8%
Week 16	1 4.5%	0 0%

19. Secondary Outcome

Title	Number of Participants With Anti-Drug Antibody (ADA)
Description	Serum samples were analyzed for the presence or absence of anti-tanezumab antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA).
Time Frame	Day 1 (pre-dose), Weeks 2, 4, 8, and 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Tanezumab
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	22
Day 1	0 0%
Week 2	0 0%
Week 4	0 0%
Week 8	0 0%
Week 16	0 0%

20. Secondary Outcome

Title	Number of Participants With Positive Urine or Serum Pregnancy Test
Time Frame	Screening, Weeks 2, 4, 8, 12, and Early termination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Tanezumab	Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.	A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
Measure Participants	22	23
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Tanezumab		Placebo
Arm/Group Description	A single dose of tanezumab (RN624 or PF-04383119) 15 milligram (mg) intravenous infusion on Day 1. Participants were followed up to Week 16.		A single dose of placebo matched to tanezumab intravenous infusion on Day 1. Participants were followed up to Week 16.
All Cause Mortality
	Tanezumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tanezumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		3/25 (12%)
Gastrointestinal disorders
Abdominal pain	0/22 (0%)		1/25 (4%)
Nausea	0/22 (0%)		1/25 (4%)
Vomiting	0/22 (0%)		1/25 (4%)
General disorders
Chest pain	0/22 (0%)		1/25 (4%)
Other (Not Including Serious) Adverse Events
	Tanezumab		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/22 (72.7%)		21/25 (84%)
Blood and lymphatic system disorders
Anaemia	1/22 (4.5%)		0/25 (0%)
Ear and labyrinth disorders
Vertigo	0/22 (0%)		1/25 (4%)
Eye disorders
Eyelid ptosis	0/22 (0%)		1/25 (4%)
Gaze palsy	0/22 (0%)		1/25 (4%)
Vision blurred	0/22 (0%)		1/25 (4%)
Visual impairment	0/22 (0%)		1/25 (4%)
Gastrointestinal disorders
Abdominal pain	0/22 (0%)		1/25 (4%)
Constipation	0/22 (0%)		1/25 (4%)
Diarrhoea	0/22 (0%)		2/25 (8%)
Dyspepsia	1/22 (4.5%)		1/25 (4%)
Nausea	2/22 (9.1%)		1/25 (4%)
Toothache	0/22 (0%)		1/25 (4%)
Vomiting	0/22 (0%)		1/25 (4%)
General disorders
Asthenia	0/22 (0%)		1/25 (4%)
Chest discomfort	0/22 (0%)		1/25 (4%)
Fatigue	1/22 (4.5%)		2/25 (8%)
Feeling cold	0/22 (0%)		1/25 (4%)
Infusion site pain	0/22 (0%)		1/25 (4%)
Injection site erythema	0/22 (0%)		1/25 (4%)
Oedema peripheral	2/22 (9.1%)		2/25 (8%)
Temperature intolerance	0/22 (0%)		1/25 (4%)
Infections and infestations
Bronchitis	0/22 (0%)		2/25 (8%)
Cystitis	1/22 (4.5%)		0/25 (0%)
Ear infection	0/22 (0%)		1/25 (4%)
Folliculitis	0/22 (0%)		1/25 (4%)
Fungal infection	1/22 (4.5%)		0/25 (0%)
Gastroenteritis	0/22 (0%)		1/25 (4%)
Hordeolum	0/22 (0%)		1/25 (4%)
Influenza	1/22 (4.5%)		2/25 (8%)
Laryngitis	0/22 (0%)		1/25 (4%)
Nasopharyngitis	1/22 (4.5%)		1/25 (4%)
Otitis media	0/22 (0%)		1/25 (4%)
Pharyngitis streptococcal	0/22 (0%)		1/25 (4%)
Sinusitis	0/22 (0%)		2/25 (8%)
Upper respiratory tract infection	2/22 (9.1%)		2/25 (8%)
Urinary tract infection	1/22 (4.5%)		2/25 (8%)
Viral infection	1/22 (4.5%)		0/25 (0%)
Viral upper respiratory tract infection	1/22 (4.5%)		0/25 (0%)
Vulvovaginal mycotic infection	0/22 (0%)		3/25 (12%)
Wound infection staphylococcal	1/22 (4.5%)		0/25 (0%)
Injury, poisoning and procedural complications
Contusion	0/22 (0%)		2/25 (8%)
Limb injury	0/22 (0%)		1/25 (4%)
Venomous sting	1/22 (4.5%)		0/25 (0%)
Investigations
Blood iron decreased	0/22 (0%)		1/25 (4%)
Cardiac murmur	1/22 (4.5%)		0/25 (0%)
Platelet count decreased	0/22 (0%)		1/25 (4%)
Weight increased	0/22 (0%)		1/25 (4%)
Metabolism and nutrition disorders
Dehydration	0/22 (0%)		1/25 (4%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/22 (18.2%)		1/25 (4%)
Back pain	1/22 (4.5%)		0/25 (0%)
Facial asymmetry	0/22 (0%)		1/25 (4%)
Muscular weakness	1/22 (4.5%)		0/25 (0%)
Musculoskeletal stiffness	0/22 (0%)		1/25 (4%)
Myalgia	0/22 (0%)		1/25 (4%)
Pain in extremity	1/22 (4.5%)		0/25 (0%)
Nervous system disorders
Allodynia	1/22 (4.5%)		0/25 (0%)
Carpal tunnel syndrome	1/22 (4.5%)		0/25 (0%)
Dizziness	0/22 (0%)		1/25 (4%)
Dysarthria	0/22 (0%)		1/25 (4%)
Dysgeusia	0/22 (0%)		1/25 (4%)
Facial neuralgia	0/22 (0%)		1/25 (4%)
Headache	2/22 (9.1%)		4/25 (16%)
Hyperreflexia	0/22 (0%)		1/25 (4%)
Hypoaesthesia	1/22 (4.5%)		2/25 (8%)
Mental impairment	0/22 (0%)		1/25 (4%)
Migraine	1/22 (4.5%)		1/25 (4%)
Paraesthesia	5/22 (22.7%)		3/25 (12%)
Tremor	0/22 (0%)		1/25 (4%)
Psychiatric disorders
Anxiety	0/22 (0%)		1/25 (4%)
Depression	1/22 (4.5%)		0/25 (0%)
Panic attack	0/22 (0%)		1/25 (4%)
Reproductive system and breast disorders
Dysmenorrhoea	1/22 (4.5%)		1/25 (4%)
Endometriosis	1/22 (4.5%)		0/25 (0%)
Genital haemorrhage	1/22 (4.5%)		0/25 (0%)
Vaginal haemorrhage	1/22 (4.5%)		0/25 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/22 (0%)		1/25 (4%)
Dyspnoea	0/22 (0%)		1/25 (4%)
Oropharyngeal pain	1/22 (4.5%)		2/25 (8%)
Pharyngeal disorder	0/22 (0%)		1/25 (4%)
Rhinitis seasonal	0/22 (0%)		1/25 (4%)
Skin and subcutaneous tissue disorders
Alopecia	0/22 (0%)		1/25 (4%)
Madarosis	0/22 (0%)		1/25 (4%)
Pruritus	0/22 (0%)		1/25 (4%)
Rash	0/22 (0%)		2/25 (8%)
Vascular disorders
Peripheral coldness	0/22 (0%)		1/25 (4%)

Limitations/Caveats

Nerve growth factor (NGF) results were reported only for plasma since a reliable assay was not available for analyzing NGF in urine. Study was prematurely terminated and recruitment was stopped due to futility shown in pre-planned interim analysis.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.