MedDataX Logo

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

NCT ID: NCT00675779

Last Updated: 2008-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

endometriosis atorvastatin oral contraception pain relief pelvic pain in women with endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

oral contraceptive + atorvastatin

Group Type EXPERIMENTAL

atorvastatin + oral contraceptive

Intervention Type DRUG

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

1

oral contraceptive

Group Type ACTIVE_COMPARATOR

oral contraceptive (Mercilon)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oral contraceptive (Mercilon)

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

Intervention Type DRUG

atorvastatin + oral contraceptive

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mercilon (Organon Schering-Plough, Poland) Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role collaborator

Biomet Polska Sp. z.o.o.

INDUSTRY

Sponsor Role collaborator

Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Poznan University of Medical Sciences

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Antoni J Duleba, MD

Role: STUDY_CHAIR

University of California, Davies, USA

Leszek Pawelczyk, MD PhD

Role: STUDY_DIRECTOR

Poznan University of Medical Sciences, Poland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Poznan University of Medical Sciences, Department of Gynecology and Obstetrics

Poznan, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

204-08

Identifier Type: -

Identifier Source: org_study_id