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

• Status: Terminated
• Trial end date: 2010-04-05
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Tanezumab

Criteria

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)