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Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

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Wyeth

Status and phase

Completed
Phase 2

Conditions

Dyspareunia
Pelvic Pain
Dysmenorrhea
Endometriosis

Treatments

Drug: ERB-041

Study type

Interventional

Funder types

Industry

Identifiers

NCT00318500
3142A2-203

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Surgical diagnosis of endometriosis within the last 10 years
  • Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception

Exclusion criteria

  • Conditions requiring the use of chronic pain therapy
  • Prophylactic use of analgesics to avoid endometriosis-related pain

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

70

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Data sourced from clinicaltrials.gov

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