EndometriosisEndoStatinNCT00675779
Efficacy Study of Atorvastatin in Pelvic Pain Relief in Women With Endometriosis
A study testing oral contraceptive (Mercilon) and atorvastatin + oral contraceptive in people with Endometriosis and Pain, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Pain
- What is being tested?
- oral contraceptive (Mercilon) and atorvastatin + oral contraceptive
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Medical Sciences, Department of Gynecology and Obstetrics
Poznan, 60-535
About this study
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
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
- Endometriosis, Pain
- Being tested
- oral contraceptive (Mercilon), atorvastatin + oral contraceptive
- Keywords
- endometriosis, atorvastatin, oral, contraception, pain, relief, pelvic pain in women with endometriosis
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral contraceptive (Mercilon)Drug
Also called Mercilon (Organon Schering-Plough, Poland)
oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months
atorvastatin + oral contraceptiveDrug
Also called Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)
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
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | oral contraceptive + atorvastatin Receives: Drug: atorvastatin + oral contraceptive |
| 1 | Active comparator | oral contraceptive Receives: Drug: oral contraceptive (Mercilon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
Measured: 3,6,12 months
Secondary outcomes (1)
inflammatory status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Biomet Polska Sp. z.o.o.
- Investigators
- Antoni J Duleba, MD, Study chair, University of California, Davies, USALeszek Pawelczyk, MD PhD, Study director, Poznan University of Medical Sciences, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675779
- Sponsor's protocol ID
- 204-08
- Acronym
- EndoStatin
- Status last verified
- May 2008
- First submitted
- 5 May 2008
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00675779
- Acronym / sponsor ID
- EndoStatin / 204-08
- Conditions
- Endometriosis, Pain
- Keywords
- endometriosis, atorvastatin, oral, contraception, pain, relief, pelvic pain in women with endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- University of California, Davis, Biomet Polska Sp. z.o.o.
- Study start
- Apr 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: atorvastatin + oral contraceptiveoral contraceptive + atorvastatin |
| 1 | Active comparator | Drug: oral contraceptive (Mercilon)oral contraceptive |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral contraceptive (Mercilon)Also: Mercilon (Organon Schering-Plough, Poland)oral contraceptive (20ug EE, 150ug DSG) 1 tablet a day p.o. for 21 days with 7 day break for 6 months | Drug | 1 |
| atorvastatin + oral contraceptiveAlso: Atrox 20 (Biofarm sp. z o.o. , Poznan, Poland)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 | Drug | 2 |
Primary outcome
pain relief
Time frame: 3,6,12 months
1 secondary outcome
inflammatory status
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni J Duleba, MD study chair
University of California, Davies, USA
Leszek Pawelczyk, MD PhD study director
Poznan University of Medical Sciences, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral contraceptive (Mercilon) and atorvastatin + oral contraceptive in people with Endometriosis and Pain, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief (time frame: 3,6,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2008.