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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Endometriosis

Treatments: Biological: Tanezumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00784693

A4091023

ENDOMETRIOSIS POC (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Tanezumab

Experimental group

Treatment:

Biological: Tanezumab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo