Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endometriosis, Pain

Intervention / Treatment
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* Drug: oral contraceptive (Mercilon)
* Drug: atorvastatin + oral contraceptive


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>oral contraceptive + atorvastatin | Drug: atorvastatin + oral contraceptive<br>* 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<br>* Other names: Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland);|
| Active Comparator: 1<br>oral contraceptive | Drug: oral contraceptive (Mercilon)<br>* oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months<br>* Other names: Mercilon (Organon Schering-Plough, Poland);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief |  | 3,6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory status |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometriosis, atorvastatin, oral, contraception, pain, relief, pelvic pain in women with endometriosis