Trial · NCT00784693
A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
NCT00784693, Phase 2, Terminated, Pfizer; results first posted 2021-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis. Trials, record NCT00784693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00784693
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Study To Investigate The Effectiveness And Safety Of Tanezumab In Treating Pain Associated With Endometriosis
- NCT number
- NCT00784693
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Endometriosis
- Interventions
- Tanezumab, Placebo
- First posted
- 2008-11-04
- Last updated
- 2021-04-30
- Results first posted
- 2021-04-30
- Limitations and 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.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Baseline, Week 8 | 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. | units on a scale | MEAN |
| SECONDARY | Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Weeks 4, 12, and 16 | Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively. | units on a scale | MEAN |
| SECONDARY | Average Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | 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. | units on a scale | MEAN |
| SECONDARY | Average Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively. | units on a scale | MEAN |
| SECONDARY | Worst Daily Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively. | units on a scale | MEAN |
| SECONDARY | Worst Daily Endometriosis Pain Score During Menstruation at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | 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. | units on a scale | MEAN |
| SECONDARY | Worst Daily Non-Menstrual Endometriosis Pain Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable at specified time point for each treatment arm, respectively. | units on a scale | MEAN |
| SECONDARY | Average Pain Score With Intercourse at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | 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. | units on a scale | MEAN |
| SECONDARY | Endometriosis Symptom Severity Score (ESSS) Total Score at Baseline, Weeks 4, 8, 12, and 16 | Baseline, Weeks 4, 8, 12, and 16 | 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. | units on a scale | MEAN |
| SECONDARY | Endometriosis Health Profile 30 (EHP-30) Score at Baseline and Week 8 | Baseline and Week 8 | Restricted FAS. Here 'number analyzed' signifies those participants who were evaluable for specified category for each treatment arm, respectively. | units on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group197
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Tanezumab | Baseline | 5.45 | Standard Deviation 1.218 | units on a scale |
| Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Placebo | Baseline | 5.50 | Standard Deviation 1.363 | units on a scale |
| Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Tanezumab | Change at Week 8 | -2.88 | Standard Deviation 2.653 | units on a scale |
| Change From Baseline in Average Daily Endometriosis Pain Score at Week 8 | Placebo | Change at Week 8 | -3.51 | Standard Deviation 1.714 | units on a scale |
| Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Tanezumab | Week 4 | 3.55 | Standard Deviation 1.999 | units on a scale |
| Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Placebo | Week 4 | 2.94 | Standard Deviation 1.814 | units on a scale |
| Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Tanezumab | Week 12 | 2.22 | Standard Deviation 2.113 | units on a scale |
| Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Placebo | Week 12 | 1.45 | Standard Deviation 1.631 | units on a scale |
| Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Tanezumab | Week 16 | 3.12 | Standard Deviation 2.320 | units on a scale |
| Average Daily Endometriosis Pain Score at Weeks 4, 12, and 16 | Placebo | Week 16 | 2.15 | Standard Deviation 2.338 | units on a scale |
1 to 10 of 197Source ClinicalTrials.gov
See all 197 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tanezumab | 23 | |
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | Treated | Tanezumab | 22 | |
| Overall Study | Treated | Placebo | 25 | |
| Overall Study | COMPLETED | Tanezumab | 20 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Tanezumab | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events178
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tanezumab | 1 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 25 | |
| other | Vertigo | Ear and labyrinth disorders | Tanezumab | 0 | 22 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 25 | |
| other | Eyelid ptosis | Eye disorders | Tanezumab | 0 | 22 | |
| other | Eyelid ptosis | Eye disorders | Placebo | 1 | 25 | |
| other | Gaze palsy | Eye disorders | Tanezumab | 0 | 22 | |
| other | Gaze palsy | Eye disorders | Placebo | 1 | 25 | |
| other | Vision blurred | Eye disorders | Tanezumab | 0 | 22 | |
| other | Vision blurred | Eye disorders | Placebo | 1 | 25 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tanezumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tanezumab | 16 | 22 |
| Total, other adverse events | Placebo | 21 | 25 |
| Total, serious adverse events | Tanezumab | 0 | 22 |
| Total, serious adverse events | Placebo | 3 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tanezumab vs Placebo: Number of Participants With Positive Urine or Serum Pregnancy Test | Trial comparisons |
| Tanezumab vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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