NCT00675779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

Enrollment Period

2.6 years

First QC Date

May 5, 2008

Last Update Submit

May 9, 2008

Conditions

EndometriosisPain

Keywords

endometriosisatorvastatinoralcontraceptionpainreliefpelvic pain in women with endometriosis

Outcome Measures

Primary Outcomes (1)

  • pain relief

    3,6,12 months

Secondary Outcomes (1)

  • inflammatory status

    6 months

Study Arms (2)

2

EXPERIMENTAL

oral contraceptive + atorvastatin

Drug: atorvastatin + oral contraceptive

1

ACTIVE COMPARATOR

oral contraceptive

Drug: oral contraceptive (Mercilon)

Interventions

oral contraceptive (Mercilon)DRUG

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

Also known as: Mercilon (Organon Schering-Plough, Poland)
1
atorvastatin + oral contraceptiveDRUG

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

Also known as: Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)
2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences, Department of Gynecology and Obstetrics

Poznan, 60-535, Poland

Location

MeSH Terms

Conditions

EndometriosisPain

Interventions

Contraceptives, Oralethinyl estradiol-desogestrel combinationAtorvastatin

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Antoni J Duleba, MD

    University of California, Davies, USA

    STUDY CHAIR

  • Leszek Pawelczyk, MD PhD

    Poznan University of Medical Sciences, Poland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2008

First Posted

May 12, 2008

Study Start

April 1, 2008

Primary Completion

November 1, 2010

Study Completion

March 1, 2011

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

PL(1)