- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00675779
Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis (EndoStatin)
May 9, 2008 updated by: Poznan University of Medical Sciences
Comparison of Pain Relief and Inflammatory Status in Women With Surgically Confirmed Endometriosis Treated With Atorvastatin, Oral Contraceptive or Combined Oral Contraceptives and Atorvastatin: Open Randomized Controlled Trial
The purpose of this study is to determine whether atorvastatin (alone or in combination with oral contraceptive) is effective in treatment of pelvic pain and inflammatory response in women with endometriosis.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Poznan, Poland, 60-535
- Poznan University of Medical Sciences, Department of Gynecology and Obstetrics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- informed written consent
- premenopausal women aged 18-45
- clinical signs and symptoms of endometriosis for minimum 3 months with endometriosis confirmed at laparoscopy or laparotomy within last 4 months - 5 years (preferably with histological confirmation)
- pain symptoms of moderate intensity (dysmenorrhoea + dyspareunia + nonmenstrual pelvic pain > 6 points on Biberoglu & Behrman scale [1981])
- no clinical signs of sexually transmitted disease
Exclusion Criteria:
- cancer of the ovary, adrenals, endometrium, uterine cervix, breasts
- pregnancy or lactation
- unexplained uterine/cervical bleeding
- hormonal therapy within last 3 months (for GnRH analogs 6 months)
- irregular menses (> 35 days) or secondary amenorrhoea (>3 months)
- other chronic disease affecting pelvic or abdominal cavity (including PID, ulcerating colitis , Crohn's disease, recurrent interstitial cystitis)
- sexually transmitted disease (gonorrhoea, Chlamydia)
- uncontrolled diabetes mellitus type I or II, VTE or other contraindications to medicine used in the study
- chronic therapy with CYP3A4 inhibitors (including ketoconazole, erythromycin and others)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
oral contraceptive + atorvastatin
|
atorvastatin 20mg po a day for 6 months + oral contraceptive (20ug EE, 150ug DSG) 1 tablet po a day for 21 days with 7 day break for 6 months
Other Names:
|
Active Comparator: 1
oral contraceptive
|
oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain relief
Time Frame: 3,6,12 months
|
3,6,12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
inflammatory status
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Antoni J Duleba, MD, University of California, Davies, USA
- Study Director: Leszek Pawelczyk, MD PhD, Poznan University of Medical Sciences, Poland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Anticipated)
November 1, 2010
Study Completion (Anticipated)
March 1, 2011
Study Registration Dates
First Submitted
May 5, 2008
First Submitted That Met QC Criteria
May 9, 2008
First Posted (Estimate)
May 12, 2008
Study Record Updates
Last Update Posted (Estimate)
May 12, 2008
Last Update Submitted That Met QC Criteria
May 9, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Endometriosis
- Pelvic Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Reproductive Control Agents
- Contraceptive Agents, Female
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Atorvastatin
- Contraceptive Agents
- Contraceptives, Oral
- Dacuronium
Other Study ID Numbers
- 204-08
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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