## Protocol Section
### Identification Module
**NCT ID:** NCT00675779

**Acronym:** EndoStatin

**Brief Title:** Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis

**Official Title:** 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

#### Organization Study ID Info
**ID:** 204-08
#### Organization
**Class:** OTHER
**Full Name:** Poznan University of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2011-03

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2008-05-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-05-09

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2010-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2008-04

**Status Verified Date:** 2008-05

#### Study First Post Date
**Date:** 2008-05-12
**Type:** ESTIMATED
**Study First Submit Date:** 2008-05-05
**Study First Submit QC Date:** 2008-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of California, Davis

**Class:** INDUSTRY

**Name:** Biomet Polska Sp. z.o.o.

#### Lead Sponsor

**Class:** OTHER

**Name:** Poznan University of Medical Sciences

#### Responsible Party

**Old Name Title:** Robert Z. Spaczynski, MD PhD

**Old Organization:** Poznan University of Medical Sciences

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Endometriosis

- Pain

**Keywords:**

- endometriosis

- atorvastatin

- oral

- contraception

- pain

- relief

- pelvic pain in women with endometriosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 44

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** oral contraceptive + atorvastatin

**Intervention Names:**

- Drug: atorvastatin + oral contraceptive

**Label:** 2

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** oral contraceptive

**Intervention Names:**

- Drug: oral contraceptive (Mercilon)

**Label:** 1

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months

**Name:** oral contraceptive (Mercilon)

**Other Names:**

- Mercilon (Organon Schering-Plough, Poland)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 2

**Description:** 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

**Name:** atorvastatin + oral contraceptive

**Other Names:**

- Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** pain relief

**Time Frame:** 3,6,12 months

#### Secondary Outcomes

**Measure:** inflammatory status

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** 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)

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Poznan

**Country:** Poland

**Facility:** Poznan University of Medical Sciences, Department of Gynecology and Obstetrics

**Zip:** 60-535

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Davies, USA

**Name:** Antoni J Duleba, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Poznan University of Medical Sciences, Poland

**Name:** Leszek Pawelczyk, MD PhD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M19918

- Name: Pelvic Pain

- Relevance: LOW

- As Found: Unknown

- ID: M7877

- Name: Endometriosis

- Relevance: HIGH

- As Found: Endometriosis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004715

- Term: Endometriosis

### Intervention Browse Module - Ancestors

- ID: D000000924

- Term: Anticholesteremic Agents

- ID: D000000960

- Term: Hypolipidemic Agents

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000057847

- Term: Lipid Regulating Agents

- ID: D000019161

- Term: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003473

- Term: Neuromuscular Nondepolarizing Agents

- ID: D000009466

- Term: Neuromuscular Blocking Agents

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Repr

- Name: Reproductive Control Agents

### Intervention Browse Module - Browse Leaves

- ID: M351

- Name: Atorvastatin

- Relevance: HIGH

- As Found: Of each

- ID: M6494

- Name: Contraceptive Agents

- Relevance: HIGH

- As Found: Veterans

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: HIGH

- As Found: Ovary

- ID: M6501

- Name: Contraceptives, Oral, Combined

- Relevance: LOW

- As Found: Unknown

- ID: M216393

- Name: Dacuronium

- Relevance: HIGH

- As Found: Proflavine

- ID: M4243

- Name: Anticholesteremic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4278

- Name: Hypolipidemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M28883

- Name: Lipid Regulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M6684

- Name: Neuromuscular Nondepolarizing Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12409

- Name: Neuromuscular Blocking Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000069059

- Term: Atorvastatin

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000003276

- Term: Contraceptives, Oral

- ID: C000003549

- Term: Dacuronium

### Misc Info Module

- Version Holder: 2024-05-24
