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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00675779

Acronym

EndoStatin

Enrollment

Registered

2008-05-12

Start date

2008-04-30

Completion date

2011-03-31

Last updated

2008-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Pain

Keywords

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

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.

Interventions

DRUGoral contraceptive (Mercilon)

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

DRUGatorvastatin + 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
pain relief	3,6,12 months

Secondary

Measure	Time frame
inflammatory status	6 months

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026