A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 75 MG AND 150 MG DOSES OF ERB-041 ON THE REDUCTION OF SYMPTOMS ASSOCIATED WITH ENDOMETRIOSIS DURING TREATMENT AND POST TREATMENT IN REPRODUCTIVE-AGED WOME

Active, not recruiting

• Conditions: Reproductive-aged women with moderate to severe symptoms related to endometriosis. Subjects will have been diagnosed with endometriosis by laparoscopy or laparotomy within 10 years before visit 1B (screening).

• Registration Number: EUCTR2006-000068-10-BE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Subjects must have had a surgical diagnosis (laparoscopy or laparotomy) of endometriosis established within 10 years before visit 1B (screening). Operative report review will be required for verification. If multiple surgeries have been performed within the previous 10 years, the operative report of the most recent laparoscopy or laparotomy will be used for eligibility requirements and source documentation.
·-Subjects must be nonpregnant, nonlactating women aged 18 to 45 years, inclusive, at the time of visit 1B (screening).
·- Subjects not undergoing a washout from oral contraceptives must have a history of regular menstrual periods (3 or more consecutive days of uterine bleeding requiring sanitary protection), with cycle lengths of 21 to 35 days, for at least 3 consecutive months before visit 1B (screening).
·- After discontinuation of oral contraceptives, subjects must have had 1 spontaneous period (ie, after the oral contraceptives withdrawal bleed) before visit 1B (screening).
·- Subjects must be sexually active (vaginal intercourse). Sexually active” is defined as full vaginal penetration at least 2 times per month or 2 failed attempts at vaginal intercourse.
·- Subjects must be willing to use highly effective nonhormonal methods of birth control (eg, sterilization, diaphragm with spermicide, or condom with spermicide) for the duration of study participation.
·- Subject must have a telephone line (analog preferred) or wireless communication instrument.
·- Subject should be able to understand the use of a personal digital assistant (PDA) device.
·- In the opinion of the investigator, the subject will comply with the protocol and has a high probability of completing the study.
·- Subjects must be willing to refrain from the use of prohibited medications during the treatment and posttreatment phases of the study.
·- During the treatment phase, subjects must be willing to use no more than the rescue medication regimen historically established during the pretreatment phase.
·- Rescue medication is limited to intake of 1 dose of analgesic per episode. If pain recurs, the subject is permitted to take a dose for each recurring episode up to the daily recommended dose for that rescue medication. Chronic narcotic use is not permitted.
·- Subjects must exhibit a positive response regarding the symptom of pelvic pain. A positive response is reported by the subject, reflects the worst episode before analgesic use, and is determined as follows:
oAt Visit 1B (Screening):
i.Subjects must have moderate to severe pelvic pain for at least 3 months before visit 1B (screening), as exhibited by a pelvic pain score of 3 or 4 on the B&B scale (the B&B scale includes the symptom of pelvic pain and assigns a point score for the degree of reported severity); AND
ii.The subject must report a pelvic pain score of at least 4 on the numeric rating scale (NRS, question 3) included in the Pelvic Pain Classification Tool (PPCT) on the basis of 1-month recall of the severity of her nonmenstrual pelvic pain before taking pain medication (if applicable).
oAt Visit 2 (Randomization):
i.The subject must have a pelvic pain score of 3 or 4 on the B&B scale (this pelvic pain score will be considered baseline); AND
ii.The subject must report a pelvic pain score of at least 4 on the NRS on the basis of 1-month recall of the severity of her nonmenstrual pelvic pain before taking pain medication (if applicable).
·- Subjects must sign and date an institution

Exclusion Criteria

Subjects who desire to become pregnant during the study.
- Subjects who have undergone hysterectomy and/or bilateral oophorectomy
- Subjects who are not candidates for estrogen therapy.
- Subjects who are pregnant or who were pregnant before visit 1B (screening).
- Subjects who are breastfeeding.
- Subjects who are not sexually active.
- The use of the following drugs within 30 days before visit 1B (screening):
a.Oral contraceptives, dermal patch containing contraceptives, injectable or implantable or insertable contraceptive hormones.
b.Oral, transdermal, or vaginally applied estrogens, progestogens, and/or androgens.
c.Aromatase inhibitors (eg, anastrozole).
- The use of the following drugs within 90 days before visit 1B (screening):
a.Progestin containing intrauterine device (IUD).
b.Monthly dose gonadotropin-releasing hormone (GnRH) analogs (eg, leuprolide acetate, 3.75 mg formulation).
c.Use of psychoactive medications (eg, selective serotonin reuptake inhibitors [SSRIs], serotonin norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants), if used for chronic pain.
d.Use of selective estrogen receptor modulators (SERMs), including raloxifene, tamoxifen, and clomiphene.
- The use of the following drugs within 10 months before visit 1B (screening):
a.Injectable/implantable progestogens (eg, medroxyprogesterone acetate depot formulation).
b.Three (3)-month dose GnRH analogs (eg, leuprolide acetate, 11.25 mg formulation).
- Use of antiepileptic medications (eg, carbamazepine, gabapentin, lamotrigine).
- Transvaginal ultrasound (TVUS) findings requiring immediate surgical intervention, as determined by the investigator, and/or evidence of findings indicative of a secondary cause of pelvic pain other than endometriosis.
- A history of endometriosis-related symptoms that are completely relieved by mild analgesics.
- Abnormal cervical cytology smear (based on the Bethesda 2001 system). Subjects with reported atypical squamous cells of undetermined significance (ASCUS) may be considered if human papilloma virus (HPV) result is negative.
- Presence or history of the following:
a.Pelvic pain secondary to other disease processes (eg, pelvic masses other than endometriomas, genitourinary disease, fibromyalgia, pelvic inflammatory disease, gastrointestinal disease, irritable bowel syndrome).
b.Known history of or suspected endometrial hyperplasia or carcinoma.
c.Thrombophlebitis, thrombosis or thromboembolic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy.
d.Ischemic heart disease, myocardial infarction, or unstable angina within 6 months before screening.
e.Cerebrovascular or cardiovascular disease.
f.Neuro-ocular disorders (eg, optic neuritis or retinal vein thrombosis).
g.Cholestasis or symptomatic gallstones (subjects who have had a cholecystectomy may be enrolled).
h.Valvular heart disease.
i.Breast cancer.
j.Estrogen-dependent neoplasia (eg, endometrial carcinoma, melanoma).
k.Liver tumors (benign or malignant).
l.Diabetes with vascular involvement, or uncontrolled diabetes.m.Undiagnosed abnormal genital bleeding within the past 6 months.
- Presence of the following:
a.Abnormality suggestive of malignancy noted on mammogram, breast examination, and/or ultrasound findings.
b.Malignancy, or treatment for malignancy, within the previous 10 years. History or active presence of basal cell or squamous cell carcinoma of the skin does not exclude the subject. History of no

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified