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Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

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Wyeth

Status and phase

Completed
Phase 2

Conditions

Endometriosis

Treatments

Drug: ERB-041

Study type

Interventional

Funder types

Industry

Identifiers

NCT00110487
3142A2-200

Details and patient eligibility

About

The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Surgical diagnosis of endometriosis within 5 years
  • Not pregnant and not lactating
  • Willing to use non-hormonal contraception, history of regular menstrual cycles

Exclusion criteria

  • Hysterectomy, surgical treatment for endometriosis within 3 months
  • Certain medications for the treatment of endometriosis
  • Previous history of a malignancy
  • Abnormalities on physical or gyn exams and abnormal lab tests

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

46

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Data sourced from clinicaltrials.gov

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