A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
Summary
The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Pelvic Pain Associated With Refractory Endometriosis
Intervention
BGS649, Placebo
Location
University of South Alabama Medical Center
Mobile
Alabama
United States
36617
Status
Recruiting
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01116440
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pelvic Pain
Pain in the pelvic region of genital and non-genital origin and of organic or psychogenic etiology. Frequent causes of pain are distension or contraction of hollow viscera, rapid stretching of the capsule of a solid organ, chemical irritation, tissue ischemia, and neuritis secondary to inflammatory, neoplastic, or fibrotic processes in adjacent organs. (Kase, Weingold & Gershenson: Principles and Practice of Clinical Gynecology, 2d ed, pp479-508)
Pain, Intractable
Persistent pain that is refractory to some or all forms of treatment.
Pelvic Floor
Soft tissue formed mainly by the pelvic diaphragm, which is composed of the two levator ani and two coccygeus muscles. The pelvic diaphragm lies just below the pelvic aperture (outlet) and separates the pelvic cavity from the PERINEUM. It extends between the PUBIC BONE anteriorly and the COCCYX posteriorly.
Cystitis, Interstitial
A condition with recurring discomfort or pain in the URINARY BLADDER and the surrounding pelvic region without an identifiable disease. Severity of pain in interstitial cystitis varies greatly and often is accompanied by increased urination frequency and urgency.
Piriformis Muscle Syndrome
A chronic PELVIC PAIN characterized by pain deep in the buttock that may radiate to posterior aspects of the leg. It is caused by the piriformis muscle compressing or irritating the SCIATIC NERVE due to trauma, hypertrophy, inflammation or anatomic variations.
Clinical Trials
The purpose of this study is to investigate if SH T 04268H is effective in the treatment of endometriosis associated pelvic pain.
this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operati...
Use of Rosiglitazone in the Treatment of Endometriosis
The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.
Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of end...
Because ovarian sex steroids fluctuations during the menstrual cycle are implicated in the pathogenesis of the endometriosis-related chronic pelvic pain (CPP), the oral contraceptives (OCs...
PubMed Articles
Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment.
PURPOSE: To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after treatment discontinuation. The study included women with endometriosis, who...
Visual pain mapping in endometriosis.
PURPOSE: To construct pain maps in order to describe the distribution of pelvic pain in a group of endometriosis patients and endometriosis-free patients, to assess the feasibility of this method. MET...
ABSTRACT Introduction. Chronic pelvic pain (CPP) is one of the most frequent symptoms in women of reproductive age. This is an enigmatic clinical condition that results from the complex interactions o...
Endometriosis in adolescence: predictive markers and management.
Endometriosis has long been thought mostly to affect the adult female population. However, awareness of possible endometriosis already in adolescence is now receiving increasing attention. It seems th...
The display of paced mating behavior in a rat model of endometriosis.
Endometriosis is a disorder associated with chronic pelvic pain and ill effects on women's sexual health. The present study examined the effects of pelvic endometriotic implants on the display of pace...
