Endometriosis
Conditions
Keywords
Endometriosis
Brief summary
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.
Interventions
DRUGERB-041
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effects and to compare the safety profile of an investigational | — |
| medication on the relief of endometriosis-related symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical and subject assessment of symptoms related to endometriosis and the | — |
| use of analgesia to relieve symptoms. | — |
Countries
United States
Outcome results
None listed